Lediga jobb CSW Therapeutics AB i Huddinge

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

Ansök    Maj 29    CSW Therapeutics AB    Forskningsingenjör, maskin
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 th... Visa mer
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 Visa mindre
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Biomedical Research Associate Preclinical Development

Ansök    Maj 14    CSW Therapeutics AB    Laboratorieingenjör, fysik
Design and support data acquisition protocols for preclinical studies involving soundwave therapy. Analyze and interpret biophysical and histological data related to angiogenesis, tissue regeneration, and cardiovascular function. Assist in the development and refinement of preclinical endpoints, with a focus on translational relevance. Contribute to the development of V&V protocols, and help document processes in line with ISO 13485 and FDA standards. Coll... Visa mer
Design and support data acquisition protocols for preclinical studies involving soundwave therapy.
Analyze and interpret biophysical and histological data related to angiogenesis, tissue regeneration, and cardiovascular function.
Assist in the development and refinement of preclinical endpoints, with a focus on translational relevance.
Contribute to the development of V&V protocols, and help document processes in line with ISO 13485 and FDA standards.
Collaborate with cross-functional teams (electronics, biology, regulatory) to ensure scientific rigor and clarity in experimental design.
Prepare documentation and materials to support grant applications, scientific publications, patent applications and regulatory submissions.
Help compile and organize a design history file (DHF) and assist in creating documentation for design for manufacturing (DFM).

Qualifications
Master’s degree in Biophysics, Biomedical Engineering, Physics, or a related field (PhD is a plus).
Experience in preclinical research, preferably involving cardiovascular models or regenerative medicine.
Understanding of histological methods, immunohistochemistry, or biomarker identification (not mandatory but helpful).
Familiarity with medical device testing, scientific documentation, and basic regulatory concepts (e.g., IEC 60601, FDA QSR).
Demonstrated ability to work interdisciplinarily, interpret biological findings from physical or analytical perspectives, and communicate clearly.
Self-driven, organized, and eager to contribute in a fast-paced startup setting.

What You’ll Get
A central role in shaping translational research at an early-stage MedTech company.
Mentorship from experienced scientists and clinicians.
Flexibility in work setup and responsibilities as the company grows.
Opportunity to impact patients with a non-invasive, potentially life-changing therapy. Visa mindre
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