CSW Therapeutics AB
Medical Device V&V Engineer (Electronics and Ultrasound Focus)
Om jobbet
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
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
CSW Therapeutics AB
FöretagCSW Therapeutics AB