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Medical Device V&V Engineer (Electronics and Ultrasound Focus)
Skicka ansökan 30 dagar kvar
Ingenjör
30 dagar kvar

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

Mer info

Anställningsform Vanlig anställning
Publicerad 2025-05-29
Lön Fast månads- vecko- eller timlön
Antal platser 1
Varaktighet 6 Månader eller längre
Hemsida Länk

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