CSW Therapeutics AB jobb

CSW Therapeutics AB is a Swedish medtech startup developing a novel wearable therapeutic device in the field of soundwave therapy, used to treat ischemic cardiovascular conditions. We're seeking a hands-on Medical Device Engineer with deep electronics expertise and proven experience in medical device testing and validation. This is a high-impact role with strong technical ownership. You'll play a central part in shaping the core technology and preparing the device for regulatory milestones. If you're excited by building from the ground up, working across disciplines, and pushing a life-changing therapy toward the clinic, we want to meet you. What You’ll Do Lead and execute verification and validation (V&V) testing for preclinical studies and regulatory submission Design, prototype, and test electronic systems for a therapeutic medical device (including power, control, and signal acquisition components) Collaborate with cross-functional teams (biology, regulatory, mechanical) to support preclinical animal testing and data acquisition Develop and document testing protocols and reports in compliance with IEC 60601, ISO 13485, and FDA QSR Support design for manufacturing (DFM), design history file (DHF), and regulatory filings What We’re Looking For PhD or MSc in Mechanical Engineering, Electronics Engineering, Biomedical Engineering or related field 3+ years experience in medical device development, especially Class II/III devices Strong background in electronics for medical applications, including circuit design, PCB layout, embedded systems, or control systems Preferable with experience in signal processing and data analysis Demonstrated hands-on experience with medical device validation, preferable in preclinical or regulatory contexts Experience with ultrasound systems (therapeutic or diagnostic) highly preferred Bonus skills Hands-on and execution-focused Comfortable with lab bench testing, prototyping, and debugging in a fast-paced setting Experience working with or managing groups in lab bench testing, CROs, or animal studies Prior work in early-stage R&D environment What You’ll Get High-impact role at the earliest stages of product development Autonomy, ownership, and visibility Close collaboration with technical founders and advisors The chance to directly influence a technology that addresses a highly unmet medical need and could transform patient outcomes