Arbetsbeskrivning
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