Medical Device V&V Engineer (Electronics and Ultrasound Focus)

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
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What We’re Looking For

• PhD or MSc in Mechanical Engineering, Electronics Engineering, Biomedical Engineering or related field
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• 3+ years experience in medical device development, especially Class II/III devices
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• Strong background in electronics for medical applications, including circuit design, PCB layout, embedded systems, or control systems
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• Preferable with experience in signal processing and data analysis
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• Demonstrated hands-on experience with medical device validation, preferable in preclinical or regulatory contexts
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• 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