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.
What is offered?
Ready to grow your career and make real impact? Join MindCapture!
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.
Job Description:
* Develop, maintain plus continuously improve risk management documentation in line with ISO 14971
* 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
* Support preparation of compliance documentation related to risk management for internal use plus external submissions
* 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
* Translate user needs product risks plus clinical insights into structured usability documentation
* Support technical documentation including design history files plus product development records
* Provide risk plus usability input for regulatory submissions plus design documentation
* Contribute to testing activities ensuring results are reflected in technical documentation plus risk files
* Review legacy device documentation identify gaps plus propose improvements aligned with current standards
* Collaborate with clinical regulatory plus internal stakeholders to integrate product data into documentation
* Support post market clinical follow up plus surveillance activities by translating field feedback into risk insights
* Provide structured technical guidance within R&D documentation plus compliance activities
Requirements:
* 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
* Strong knowledge of ISO 14971
* Good understanding of ISO 13485 within product development plus documentation processes
* 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
* Strong analytical thinking structured working style plus ability to provide technical direction
* Excellent communication skills with ability to collaborate across R&D Clinical plus Regulatory teams
* On site presence of 4 days per week
Are you ready to make a real difference in healthcare?
Join our dynamic team and help drive innovation in medical devices.
Apply now and let’s make an impact together!
Want to learn more? Discover all opportunities at www.mindcapture.com.
If MindCapture sees a potential fit, we’ll get in touch as soon as possible.
If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep your profile in mind for future roles that could suit you better.