SmartCella Holding AB jobb

Operator ProductionPrecision - Care - Impact Are you someone who takes pride in doing things carefully, accurately, and with purpose? In our team, your attention to detail can make a real difference. As Operator Production, you will help manufacture the Extroducer® — an innovative delivery device designed to support targeted therapies for patients in need. The position is full-time and on-site in Tullinge, in a team where transparency, trust, creativity, and collaboration guide how we work. About the role As Operator Production, you will learn and perform manufacturing steps for the Extroducer® according to approved instructions and procedures, contributing to precision, quality, and continuous improvement as we grow. Together with your colleagues, you will: Manufacture the Extroducer® according to approved work instructions. Perform incoming inspections of purchased and received components. Report deviations and support a strong quality culture. Contribute ideas that help improve and develop the production setup. Qualifications and experience We believe you bring: Minimum Swedish upper secondary school education, or equivalent. Experience from precision-based work, such as medical device production, electronics, fine assembly, or similar. A meticulous work approach, manual dexterity, and a strong quality mindset. Experience with quality control, measurement tools, and preferably ISO 13485 or similar quality standards. Troubleshooting skills and confidence working safely with tools, machinery, and production systems. Personal skills and behaviors As a person, you are structured, reliable, collaborative, and detail oriented. You communicate clearly, take pride in accurate work, and contribute to a team where everyone’s effort matters. You are curious, flexible, and open to learning. You have good documentation skills, are proficient in Swedish and English, and are comfortable using Microsoft Office and ERP systems. Why join us? You will be part of our journey to pioneer targeted therapies for patients in need. We are a diverse, international team where knowledge sharing, support, and a shared purpose drive progress. Here, your contribution is visible, your ideas are welcome, and your attention to detail can make a real difference. Apply now If this sounds like a place where you would thrive, we would love to hear from you. Please send us your application as soon as possible, as we review applications on an ongoing basis. 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.

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.