Looking for a R&D engineer role in medical devices where you can combine risk management, usability engineering plus technical documentation? This opportunity allows you to contribute as a senior technical expert supporting compliant product development in the healthcare sector.
We offer competitive salaries, a full benefits package with meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance plus a company car. You also get the opportunity to shape your future through personalised training plus development.
At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.
You will work as a MindCapture consultant or freelancer for an international market leader in the healthcare industry.
Prepare plus update risk management files for new plus existing medical devices ensuring traceability with development activities
Perform risk assessments including FMEA plus failure mode analyses to identify hazards plus define mitigation measures
Contribute to usability engineering documentation aligned with medical device standards plus regulatory expectations
Create usability engineering files including use related risk analyses plus validation plans
Support technical documentation including design history files plus product development records
Contribute to testing activities ensuring results are reflected in technical documentation plus risk files
Collaborate with clinical regulatory plus internal stakeholders to integrate product data into documentation
Provide structured technical guidance within R&D documentation plus compliance activities
Bachelor’s or Master’s degree in biomedical engineering mechanical engineering medical technology or related field
Minimum 5 years experience in R&D design assurance risk management or technical documentation within medical devices
Experience with risk management files FMEA usability documentation plus technical documentation for medical devices
Exposure to regulatory submissions design history files post market surveillance plus post market clinical follow up
Experience with testing methodologies verification or validation is a strong asset
Excellent communication skills with ability to collaborate across R&D Clinical plus Regulatory teams
Join our dynamic team and help drive innovation in medical devices.
If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match.