Civilingenjör, medicinsk teknik

Senior R&D Engineer - Medical Device Product Development Are you passionate about creating innovative medical devices that improve people's lives and shape the next generation of medical devices? We are looking for a highly experienced Mechanical Design Engineer with strong expertise in injection-molded plastic parts, polymer materials, and medical device development. You will be an important part of our R&D team, driving development from concept through industrialization and product launch supporting growth of our medical device portfolio. We passionately strive to make a real difference every day to everyone who needs our products and services. We can offer you an exciting and challenging job in a company that is committed to making a difference every day. We have a culture of team spirit where sharing knowledge and finding new ways to tackle challenges together is key. In this role you will work with many different cross-functional teams, and we can promise you a challenging learning journey. What You Will Do Lead mechanical design development within innovation, NPD and product care projects. Own technical requirements, specifications and design solutions. Drive device design and DFM activities. Develop CAD models and drawings using PCT(Creo) and Windchill. Plan and execute design verification and validation activities. Ensure compliance with Design Control and regulatory requirements. Contribute and act as Subject Matter Expert(SME) for assigned task within department Participate in risk management activities according to ISO 14971. Support industrialization, design transfer and supplier collaboration. Who You Are Creative and innovative problem solver. Strong cross-functional collaborator. Results-oriented with a proactive mindset. Excellent communicator in English. Well structured, and confident in mechanical engineering tools Qualifications B.Sc. or M.Sc. in Mechanical Engineering or equivalent. Minimum 10 years of product development experience. Strong expertise in injection molding and polymer materials and their manufacturing processes. Medical device experience is strongly preferred. Experience with ISO 13485, Design Control and Design Transfer, DFM. Strong experience in solid modeling(CAD) and working in PDM environment Why Join Wellspect? Meaningful work improving quality of life. Opportunity to influence future innovations. Collaborative culture and skilled colleagues. Flexible and supportive work environment. Location: Mölndal, Sweden (on-site position) Applications are reviewed continuously, We look forward to hearing from you!

Development Engineer – BONESUPPORT Come and join BONESUPPORT as Development Engineer! This is an opportunity to take an active role in the design and development of innovative medical devices, from early concepts to finalized products and manufacturing. BONESUPPORT is an innovative and growing medical device company based in Lund, Sweden. The company develops and commercializes injectable bio-ceramic bone graft substitutes for the treatment of bone disorders. To further strengthen our Development & Engineering department, we are now looking for a Development Engineer with a strong technical background and hands-on experience in mechanical design, product development and verification. Your role As Development Engineer, you will be involved in the development of new medical devices as well as improvements to existing products. You will work throughout the product development process, from concept development and mechanical design to verification, validation and transfer to manufacturing. The role has a strong technical focus, combining hands-on mechanical engineering and CAD design with testing, material selection and manufacturing considerations. You will be responsible for developing robust technical solutions that meet functional requirements and can be efficiently manufactured. You will work closely with colleagues within R&D, Operations, Quality Assurance and Regulatory Affairs, as well as external suppliers and manufacturing partners. Your main responsibilities will include: Design and develop medical device components and assemblies using 3D CAD tools. Execute design activities through all product development phases. Create and maintain engineering drawings, technical specifications and design documentation. Perform mechanical design activities, including material selection, tolerance analysis and component optimization. Develop technical solutions with consideration for Design for Manufacturing (DFM), Design for Assembly (DFA) and Design for Reliability. Collaborate with suppliers and manufacturing partners on tooling, injection molding and manufacturing optimization. Develop, plan and perform verification and validation testing. Establish test methods and prepare test protocols and reports. Analyze test results, identify potential improvements and provide recommendations for design modifications. Participate in design reviews, risk management activities and cross-functional development projects. Support design transfer activities and contribute to design control documentation in accordance with applicable regulatory requirements. Qualifications We are looking for a technically skilled engineer with practical experience in mechanical design and product development  within the medical device industry. To succeed in this role, we believe you have: A technical academic background at Bachelor's level or higher, preferably in Mechanical Engineering or a related field. Relevant experience in mechanical design and product development within the medical device industry. Hands-on experience with 3D CAD software, such as SolidWorks, Inventor or similar. Experience in creating engineering drawings, technical specifications and detailed design documentation. Good understanding of materials, manufacturing processes and mechanical design principles. Experience in planning, performing and documenting design verification activities, including test methods, protocols and reports for mechanical and functional testing. Knowledge of Design for Manufacturing (DFM), Design for Assembly (DFA) and tolerance analysis. Ability to analyze technical problems, evaluate test results and develop practical engineering solutions. Good technical writing and documentation skills. Preferred qualifications It is an advantage if you also have experience or knowledge in: Injection molding, tooling and component manufacturing. Design Control and requirements management. Risk management according to ISO 14971. Usability engineering according to IEC 62366. Medical device safety standards. Implantable medical devices. Statistical methods and test method development. Design transfer and collaboration with external manufacturing partners. Personal qualities We believe you are analytical, structured and solution-oriented, with a strong interest in technical problem-solving and product development. You enjoy working hands-on with engineering challenges and have the ability to translate technical requirements into practical and reliable design solutions. You take ownership of your tasks, work independently and proactively drive activities forward. At the same time, you value collaboration and enjoy working with colleagues from different technical and functional backgrounds. You are comfortable working in an environment where technical challenges require both attention to detail and an understanding of the complete product development process. Why BONESUPPORT? At BONESUPPORT, you will have the opportunity to contribute to the development of innovative medical devices that make a difference for patients. You will join a growing company where product development, engineering and manufacturing expertise come together. The position offers an opportunity to take an active role in technical development projects and contribute to the continued development of BONESUPPORT's products. Location: Lund, Sweden Application SKÅNESTOR is managing the recruitment process on behalf of BONESUPPORT. Please apply directly through this advertisement. For questions, please contact SKÅNESTOR at [email protected].

Come and join BONESUPPORT as Design Control Engineer!  This is an opportunity to apply your expertise in design control, risk management and technical documentation, contributing to the continued development and lifecycle management of innovative medical devices. About BONESUPPORT BONESUPPORT™ AB is an innovative and growing medical device company based in Lund, Sweden. The company develops and commercializes injectable bio-ceramic bone graft substitutes for the treatment of bone disorders. BONESUPPORT's products are based on its patented CERAMENT® technology platform, with the aim of improving treatment outcomes for patients. About the role As Design Control Engineer, you will join the Development & Engineering department and play an important role in product lifecycle management, with a focus on design control, change control and risk management. You will contribute to maintaining and developing the technical documentation for BONESUPPORT's products, ensuring compliance with applicable regulatory requirements, standards and internal procedures throughout the product lifecycle. Risk management is an important part of the role, and you will have the opportunity to contribute your knowledge and experience to further strengthen this area within the organization. Your main responsibilities will include: Manage and support design control and change control activities for existing products and product improvements. Prepare, review and maintain technical documentation, including design and development documentation. Participate in risk management activities, including risk assessments and FMEA, in accordance with ISO 14971. Plan, conduct and document verification and validation activities. Support requirements management and maintain traceability between requirements, risks and verification activities. Contribute to usability engineering activities in accordance with applicable standards. Perform gap analyses related to updated regulatory requirements, standards and guidelines. Develop and maintain technical procedures, specifications and other quality system documentation. Collaborate with cross-functional teams to support product changes, investigations and continuous improvements. You will work closely with Quality Assurance, Regulatory Affairs, R&D, Operations and other functions, as well as external partners. Qualifications We are looking for a structured and motivated engineer with practical experience in design control and technical documentation within the medical device industry. To succeed in this role, we believe you have: A technical academic background at Bachelor's level or higher. Relevant experience from the medical device industry. Hands-on experience with design control, change control and technical documentation. Experience in requirements management and design verification activities. Knowledge of risk management according to ISO 14971, including FMEA and risk management documentation. Knowledge in Usability engineering according to IEC 62366. Good understanding of applicable medical device regulations and standards (EU and US). Strong technical writing and documentation skills. Preferred qualifications It is an advantage if you also have experience or knowledge in: Implantable medical devices. Sterilization processes. Statistical methods and test method development. Personal qualities We believe you are structured, analytical and detail-oriented, with a practical and solution-focused approach to your work. You are comfortable taking responsibility for your tasks and driving activities forward independently, while recognizing the importance of collaboration and knowledge sharing. You communicate clearly, take initiative and enjoy working with colleagues from different functions. You are motivated by continuous improvement and contributing to the development of both products and processes. Why BONESUPPORT? At BONESUPPORT, you will have the opportunity to work with innovative medical devices that make a difference for patients. You will join a growing company with dedicated colleagues and a collaborative working environment. The role offers an opportunity to apply and further develop your expertise in design control and risk management while contributing to the continued development and maintenance of BONESUPPORT's products. Location: Lund, Sweden Application SKÅNESTOR is managing the recruitment process on behalf of BONESUPPORT. Please apply directly through this advertisement. For questions, please contact SKÅNESTOR at [email protected].

Därför är detta jobb för dig Enkelt, du vill vara kreativ och innovativ i att lösa tekniska problem. Och det är precis vad vi erbjuder dig. Du är experten; du berättar för oss vilken lösning som du anser är bäst. Du kommer inte att vara ensam, nyckelordet är samarbete. Tvärfunktionella team skapas för att lösa projekt, snarare än att välja projekt för en redan befintlig grupp. Produkter och affärsområden kommer att skilja sig åt och du kommer att bygga nya spännande lösningar. Din utveckling är vår utveckling. Det vi erbjuder dig är ingen förutbestämd väg att följa. Vi gör saker på vårt eget sätt. Du har kontroll över din utveckling, oavsett vilken riktning du vill ta. Oavsett om det handlar om att nå en ny roll i framtiden eller fördjupa dig inom en specifik teknik, finns vi här för att hjälpa dig framåt. Du kommer att arbeta inom vårt affärsområde Hardware & Design där vi kombinerar bred ingenjörskompetens med djup specialistkunskap och ett användarcentrerat förhållningssätt – för att utveckla fysiska produkter och digitala upplevelser hela vägen från koncept till storskalig produktion. Arbetsuppgifter Konstruktion i produktutvecklingsprojekt, antingen vidareutveckla befintliga produkter eller skapa något helt nytt Samarbeta med tvärfunktionella team för att lösa komplexa problem Kommunicera med både experter och icke-experter om komplexa tekniska frågor Kvalifikationer Vi söker dig som trivs med att brottas med knepiga tekniska utmaningar och att analysera. Du tycker om att tillsammans med teamet bryta ner dessa utmaningar för att nå den bästa lösningen. Du är en person som tycker om att dela med dig av dina kunskaper samtidigt som du självständigt kan driva ditt eget arbete framåt. Utöver dina personliga egenskaper behöver du ha följande: Ingenjörsexamen inom maskinkonstruktion eller produktutveckling Minst 4 års erfarenhet av att arbeta som mekanikkonstruktör, inom konstruktion och produktutveckling Erfarenhet av att arbeta inom Life sciences eller MedTech Goda kunskaper i CAD och PDM-system Du kommunicerar flytande på svenska och engelska En spännande resa med Knightec Group Semcon och Knightec har gått samman som Knightec Group. Tillsammans bildar vi Norra Europas ledande strategiska partner inom produkt- och digital tjänsteutveckling – hur häftigt är inte det? Med en unik kombination av tvärfunktionell expertis och en holistisk förståelse för affärer hjälper vi våra kunder att förverkliga sina strategier – från idé till färdig lösning. På Knightec Group finns kompetensen, attityden och drivkraften som krävs för att anta de mest utmanande och innovativa projekten. För våra medarbetare innebär detta fantastiska möjligheter att vara med och forma framtiden genom meningsfulla projekt i teknikens absoluta framkant. Här får du inte bara utvecklas och växa, utan också bli en del av något större. Låter det som platsen för dig? Häng med på en spännande resa! Praktisk information Detta är en tillsvidareanställning med en provanställning på sex månader, placerad på vårt kontor i Uppsala, Dragarbrunnsgatan 45. Resor i tjänsten kan förekomma till våra kunder. Startdatum enligt överenskommelse. Skicka in din ansökan så snart som möjligt, men senast 2026-11-27. Om du har några frågor om tjänsten är du välkommen att kontakta Paola Banegas, Talent Acquisition Partner. Observera att vi, på grund av GDPR, endast tar emot ansökningar via vår karriärsida. Vi ser fram emot att höra från dig!

Vi på Together Tech samarbetar med många branschledande företag inom medicinteknik och variationen på kunder och projekt är stor. Nu söker vi dig som trivs i gränslandet mellan teknik, kvalitet och regulatoriska frågor. Uppdraget är hos ett internationellt medicintekniskt bolag vars produkter förbättrar vardagen för människor med kroniska besvär. Om uppdraget Du blir en nyckelperson i både nyutveckling och förvaltning av befintligt sortiment. I utvecklingsprojekten leder du Design Control och samordnar tekniska leveranser. Parallellt driver du förbättringsarbete på lanserade produkter, till exempel produktförändringar, leverantörsbyten, kvalitetsförbättringar, kostnadsoptimering och livscykelfrågor. Målet är att produkterna förblir säkra, effektiva, regelefterlevande och konkurrenskraftiga över tid. Arbetsdagarna varierar. Ena veckan förbereder du ett projekt inför designverifiering, nästa leder du utvärderingen av en ny leverantör eller ett arbete för att stärka kvalitet och leveranssäkerhet. Ansvarsområden Leda Design Control i utvecklingsprojekt och driva produktförändringar under hela livscykeln Medverka vid utveckling, design transfer, lansering och underhåll av medicintekniska produkter Upprätta, granska och underhålla den tekniska filen enligt gällande regelverk och standarder, såsom MDR, IVDR, ISO 13485, ISO 14971, IEC 62304 och IEC 60601 Leda tekniska bedömningar av design, material, tillverkningsprocesser, leverantörer och förpackning. Leda avvikelseutredningar, rotorsaksanalyser och riskbedömningar Driva förbättringar inom kvalitet, leveranssäkerhet, kostnad och riskhantering Samarbeta brett med R&D, produktion, QA/RA, kliniska och medicinska funktioner samt kommersiella team Vidareutveckla processer, strukturer och arbetssätt, bland annat för dokumentationshantering Din profil Du är nyfiken, driftig och trivs i ett team. Du arbetar strukturerat, navigerar enkelt bland många intressenter och motstridiga prioriteringar, och väger tekniska, regulatoriska, kvalitetsmässiga och affärsmässiga hänsyn mot varandra utan att tappa slutanvändaren ur sikte. Din bakgrund Relevant akademisk examen. 5–10 års erfarenhet av produktutveckling, QA eller produktunderhåll inom medicinteknik eller annan reglerad bransch, med fokus på Design Control, Change Control och teknisk dokumentation. Stark teknisk förståelse, gärna inom elektronik, mekanik, mjukvara eller material. Tidigare arbete med MDR, ISO 13485, ISO 14971, IEC 60601 och IEC 62366. Erfarenhet av PLM-system för produktutveckling, ändringshantering och livscykelhantering. Mycket god kommunikationsförmåga, skriftligt och muntligt, på svenska och engelska. Together Tech för hållbar produktutveckling Hos Together Tech får du möjlighet att arbeta i olika branscher och uppdrag, antingen i kundprojekt på plats eller inhouse på våra kontor. Du arbetar tillsammans med kollegor som delar ett intresse för teknik och hållbarhet, med en gemensam ambition att skapa långsiktiga lösningar. Better World Tech är inte bara ett uttryck – det genomsyrar vårt sätt att arbeta. Din utveckling & vårt stöd🌱 Din utveckling och ditt välmående är viktigt för oss varpå vi erbjuder förmåner som stöttar dig och din karriär på bästa sätt: Friskvårdsbidrag på 4 000 kr per år samt rabatter på träningsaktiviteter Sociala teamaktiviteter – från afterworks till sportaktiviteter Individuella utvecklingsplaner och möjlighet att växa genom olika uppdrag och projekt Kurser inom hållbarhet och andra områden inom ramen för din roll och dina mål Vi är stolta över att vara utsedda till en av Sveriges mest attraktiva arbetsgivare 2026, 2025 och 2024 av Karriärföretagen 🌟 Urval sker löpande, så skicka gärna in din ansökan redan idag. Vill du veta mer om oss, besök gärna vår hemsida www.togethertech.com För frågor om rollen, kontakta rekryterande ledare Sofia Nilsson, på telefon 0737-179438

When you can’t breathe, nothing else matters. That’s why a career at Breas Medical matters. Our mission is to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality and customer focus. Are you our next Production Support Engineer? Are you an engineer who enjoys solving technical challenges and turning ideas into reliable manufacturing solutions? You may already have experience in production or manufacturing engineering, or you may be at the beginning of your career with a relevant technical education and an interest in medical technology. As a Production Support Engineer within R&D Sweden, you will play an important role in strengthening our production processes and supporting the introduction of new products and design changes. Working closely with Production, R&D, Quality and other cross-functional teams, you will help ensure that our products are manufactured safely, efficiently and in accordance with applicable quality and regulatory requirements. This is an opportunity to combine hands-on production support with continuous improvement, technical problem-solving and long-term development in a highly regulated and meaningful industry. The position is full-time, permanent and based on-site at Breas Medical’s headquarters in Mölnlycke, Sweden. Main responsibilities Provide technical support to Production and help resolve manufacturing and quality-related issues. Lead or support design transfers, new product introductions and the implementation of design changes. Develop and improve manufacturing processes, methods, tooling, equipment and work instructions. Plan, perform and document process, verification and validation activities. Analyse production performance and contribute to improvements in product quality, production yield, safety and cost efficiency. Support Lean initiatives and collaborate with cross-functional teams to achieve shared goals. About you You are a curious and solutions-oriented engineer who enjoys turning technical challenges into practical improvements. You work in a structured way, with attention to quality, safety and documentation. Collaboration comes naturally to you, and you are comfortable communicating with colleagues across different functions and areas of expertise. You have an open mindset, enjoy working close to production and are motivated by contributing to products and processes that make a meaningful difference. To be successful in this role, we believe you bring some of the following experience and skills: A university degree in production engineering, medical engineering, mechanical engineering, electronics or another relevant technical field. Experience or a strong interest in production, manufacturing processes or medical technology. An understanding of mechanics, electronics and software, and how these areas interact within a product. Experience or knowledge of Design for Manufacturing, design transfer, verification, validation, tooling or process development. A structured approach to problem-solving and technical documentation. Good spoken and written Swedish and English. Previous experience in production or manufacturing engineering is an advantage but not essential. We also welcome applications from recent graduates with a relevant educational background and an interest in developing within production engineering and medical technology. Knowledge of regulatory requirements and standards for medical devices, such as ISO 13485, MDR, IEC 60601-1 or FDA requirements, is considered an advantage. Be More with us Join Breas and become part of a company where your experience, ideas and ambition can make a meaningful difference. Apply today and explore what it means to Be More. Expected recruitment timeline Applications will be reviewed continuously. More about us Founded in 1991 in Gothenburg, Sweden, Breas Medical is a global specialist in home mechanical ventilation and airway clearance, with a growing portfolio of sleep therapy solutions. Our purpose is to help the world breathe better. We connect people throughout the respiratory journey by bringing together insights, innovation and care. Our solutions form a connected ecosystem that includes ventilation, airway clearance, interfaces, accessories, connectivity, services and clinical education, supporting patients, caregivers and healthcare professionals from therapy initiation to long-term care at home. Headquartered in Sweden, Breas has more than 300 employees and subsidiaries across Europe, Asia-Pacific and the Americas. Together with our network of specialised distributors, we serve customers in over 40 countries worldwide. Find out more: Breas Medical

Integration Diagnostics and its core products, Penguin RFA and Osseo100 measures dental implant stability to enable clinicians to decide when to load an implant. The technique has been developed in close cooperation with clinicians and experts in the field of dental implantology. Resonance Frequency Analysis (RFA) and the measurement unit Implant Stability Quotient (ISQ) were introduced into the dental implant industry in 2001 and are now established methods of measuring implant stability and osseointegration. In 2015, in response to the dental community’s need for an accessible ISQ measuring system, Integration Diagnostics Sweden AB (IDSAB) was founded. Sales have developed rapidly with clients today in + 70 countries globally. In 2018, Integration Diagnostics became part of the Japanese company Nakanishi Inc. Nakanishi Inc., is a world-leading company of professional dental instruments with the world’s top-share brand “NSK”. All its products are developed and manufactured in Japan and distributed to 135 countries around the globe. The NSK Group has 14 subsidiaries worldwide and has established a strong global sales network. We are currently looking for a, Junior R&D Engineer – Medtech As a Junior R&D Engineer, you will be part of a small and agile R&D team, working closely with the R&D Director, who is also the founder of the company. This role offers a unique opportunity to gain hands-on experience across the entire product lifecycle, from concept development and testing to technical documentation and production support. You will play an active role in maintaining and improving existing products while supporting the development of future innovations within IDSAB's medical device portfolio. Key responsibilities: Contribute to the maintenance, optimization, and continuous improvement of commercially available products. Support the development and refinement of R&D methodologies, development processes, verification activities, and testing procedures in collaboration with the R&D team. Manage existing technical documentation and prepare new technical documentation when required. Work cross-functionally with colleagues in R&D, Quality Assurance, Production, and Product Management. In this position, your daily work has a wide scope and is conducted in a dynamic, innovative international working environment. Qualifications • Master of Science in Engineering (M.Sc.) or Bachelor of Science in Engineering (B.Sc.) in Electronics, Engineering Physics, Medical Engineering, or a related field. • Good knowledge about medical device development • Fluent in Swedish and English Preferred Experience The following experience is considered an advantage: Hands-on experience from experimental work, laboratory environments, or workshop activities. Practical experience gained through master's thesis projects, personal side projects, student competitions, or involvement in student organizations focused on engineering, electronics, robotics, or product development. Experience in prototyping, CAD, testing, troubleshooting, or building technical systems. Previous experience within the medical device industry is highly valued. To succeed in this role, you are a user- and patient centric person with a strong drive to provide innovative products. You have a broad technical interest, and you can navigate in both hardware and software development. You will be part of an exciting and challenging journey shaping the company’s future and taking the business to new heights. In this role you will have a great opportunity to make an impact and improve the products and solutions we supply to the market, and you will have a big variation in activities. Application To apply, please send your CV to [email protected] By submitting your application, you also consent to us storing your personal data, including CV & cover letter. You can revoke the consent whenever you want.

Senior Medical Device Quality & Regulatory Engineer At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale. Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder. Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally. We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure. The Role You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory. This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain. What You’ll Do Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control) Own and maintain Technical Documentation / Technical Files / DHFs / DMRs Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements Collaborate closely with R&D on design changes and process improvements Support and continuously improve our ISO 13485-certified QMS Support regulatory submissions and updates (EU MDR, FDA) Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness Work cross-functionally with product, regulatory, and operations teams What We’re Looking For You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing. Core Competencies Very strong technical project management skills Strong technical experience with active medical devices Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820) Hands-on experience with supplier and manufacturing quality control Proven experience managing Technical Files / DHF / DMR Expertise in ISO 13485 QMS implementation and maintenance Experience with FDA regulations (QMSR) and EU MDR Experience with FDA inspections and/or Notified Body audits Bonus (Highly Valuable) Experience with FDA PMA devices (Class III) and PMA supplements Background in combination hardware/software medical devices Quality management system automation, eQMS & AI-tools. Experience working closely with Asia-based contract manufacturers Experience working with neurotech. Who You Are You take ownership and operate with high autonomy You’re structured, detail-oriented, and pragmatic You can translate regulatory requirements into efficient processes You enjoy working cross-functionally with engineers and operators You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing Why join us? Work on a clinically proven treatment for one of the world’s largest health problems Be part of a company transitioning into global scale (including the US market) Own meaningful parts of the quality and regulatory backbone of a US Class III device Join a mission-driven team combining science, engineering, and real-world impact Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.

Start your engineering career by helping shape the future of medical device innovation Hands-on testing • Collaboration • Meaningful innovation Are you a hands-on engineer who enjoys testing, problem-solving, and turning data into practical improvements? We are looking for a curious and structured Test Engineer to join our R&D team and support the development of safe, high-quality medical device solutions. About the role In this role, you will plan, perform, document, and analyse engineering tests for products, prototypes, components, and test methods. You will work closely with colleagues across R&D, Operations, Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs, and external suppliers. You will be part of a collaborative environment where practical engineering, quality, and continuous improvement go hand in hand. The role reports to the Head of R&D and Clinical Affairs. What you will doTesting, verification and method development Plan, conduct, and document verification, validation, feasibility, and routine engineering tests. Analyse test data, interpret results, and prepare clear reports with recommendations for improvement. Develop and improve test procedures in line with project needs, safety requirements, and quality expectations. Equipment, calibration and quality support Support equipment maintenance, calibration, gauge R&R activities, and method verification or validation when needed. Contribute to safe, compliant, and well-controlled laboratory and manufacturing-related testing activities. Collaboration and continuous improvement Collaborate with cross-functional teams to troubleshoot testing, process, and equipment-related challenges. Work with suppliers and vendors to support installation, maintenance, and continuous improvement of equipment and systems. Compliance and safety Together with QA/RA, you will help ensure that testing is performed in line with internal procedures, safety requirements, and relevant standards such as ISO 13485, ISO 14971, ASTM standards, FDA Quality System requirements, and EU MDR where applicable. Who we are looking forA great opportunity to grow This is a great opportunity for someone early in their engineering career who wants to grow in an exciting and meaningful field. We are looking for a curious, structured, and hands-on person who enjoys learning, solving problems, and working closely with others to turn ideas and test results into practical improvements. You have a Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, or a related field, together with some relevant experience from engineering testing, validation, laboratory work, product evaluation, internships, academic research, or engineering projects. You have a basic understanding of test design, validation principles, structured documentation, CAD software, and data analysis tools — and you are eager to keep developing your skills. Nice to have Experience from the medical device industry, particularly catheter development or manufacturing, is an advantage. Proficiency in Swedish is also a plus. Practical information The role includes work in both office and laboratory or manufacturing environments, with a strong focus on safe and compliant ways of working. Why join us? You will join a team where your curiosity, practical mindset, and attention to quality can make a real difference. Together, we develop solutions that support meaningful progress in medical device innovation. Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible. The SmartCella group consist of SmartCella Holding AB, SmartWise Sweden AB and SmartCella Solutions AB with a total of 32 employees from 11 nationalities. We are a global drug delivery company pioneering innovative delivery solutions for targeted therapies, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors). We are an international and diverse team of scientists, visionary innovators, and experienced business leaders, dedicated to shaping the future of targeted therapies.

Do you have deep expertise in fluidics and flow-cell design for analytical instrumentation? Are you excited by the opportunity to drive development from early concepts to production and product care? Join Moleculent and play a key role in developing a cutting-edge life science instrumentation! Moleculent is on a mission to build products that yield new insights into the molecular foundation of human biology. This is a chance to join a focused and dedicated team with extensive experience building successful life-science companies and products. This is a permanent position based in Solna, Stockholm. The position is full-time and based at Moleculent’s headquarters in Solna, Stockholm. Please don’t wait to submit your application. We review candidates on an ongoing basis, and the position may be filled before the final application deadline. Applicants must be eligible to work in Sweden without sponsorship. JOB DESCRIPTION As a Senior Systems Engineer – Fluidics at Moleculent, you will be responsible for flow cells and fluidics design throughout the entire product development life cycle – from concept development and prototyping to design transfer and product care. You will work closely with cross-functional teams and external partners to develop robust and scalable solutions for advanced analytical instrumentation. You will combine hands-on laboratory work with system-level thinking and project leadership responsibilities. Key responsibilities include: Lead flow cell and fluidics design activities, including design, testing, troubleshooting, and verification Drive development of new flow cell concepts and consumable designs Support flow cell production engineering and production troubleshooting Ensure production equipment is maintained, supported, and qualified Participate in and drive instrument-level testing and verification activities Lead or contribute to throughput improvement initiatives Manage system-related project activities and integration work Contribute to early-stage conceptual development for future instrument generations Collaborate closely with R&D, Operations, Product Management, Biochemistry teams, suppliers, and contract manufacturers QUALIFICATIONS To fit the role, you most likely hold an MSc in Technical Biology, Molecular Biotechnology, Material Science, Mechanical Engineering, or a related field. A PhD within a relevant discipline is considered a strong advantage. Fluent written and spoken English is required. You have several years of experience working with fluidics and flow cell development in analytical or life science instrumentation environments. You are comfortable moving between development, testing, production support, and cross-functional collaboration. We believe you have: Experience with fluidics design in analytical systems Experience with consumable prototyping, product development, and transfer to manufacturing Knowledge of plastics and adhesives commonly used in life science or medical technology products Experience from product development of instrumentation within Life Science Hands-on laboratory experience and practical troubleshooting skills Project management or project leadership experience Experience with testing, verification, and troubleshooting activities Good understanding of integrated hardware/software instrumentation systems Nice to have: Experience with flow simulations Experience with requirements engineering and formal verification methodologies Experience working with analytical instruments, in vitro diagnostics systems, or medical devices Experience writing test specifications and verification documentation Swedish language skills You are hands-on, analytical, and solution-oriented, with a strong ability to navigate complex technical challenges. You enjoy working closely with both development and production teams and thrive in collaborative environments where innovation and quality are central. You are structured in your approach while remaining pragmatic and adaptable in a fast-moving environment. You take ownership of your work and enjoy driving projects forward together with others. MOLECULENT We believe innovative biotechnology has enabled massive leaps forward in understanding the composition of tissues and organs. However, the functional understanding of how cells communicate in their native context and form these complex systems has just begun. We develop technology designed to uncover radical new insights into the cellular level of human biology by mapping the communication between cells in human tissue and providing meaningful data. https://www.moleculent.com/ Please note that Moleculent manages the recruitment process for this position. External recruitment agencies are requested to refrain from direct contact with us in this regard.