Product Development Engineer
Coloplast
full-time
Posted on:
Location Type: Office
Location: Minneapolis • Minnesota • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Apply foundational engineering principles to develop and test new product and technology concepts through the entire company’s stage-gate process
- Maintain detailed documentation throughout all phases of product development
- Support preparation of technical content for regulatory submissions (e.g., 510(k), IDE, CE marking)
- Collaborate with Quality, Regulatory, and Manufacturing teams to ensure design outputs meet compliance, usability, and manufacturability requirements
- Translate customer and clinical needs into design inputs and product specifications
- Support process development, scale-up, and technology transfer to manufacturing
- Support risk management activities
- Design, perform and report on laboratory experiments, methods development and product testing
- Contribute to verification and validation (V&V) activities, including test method development, execution, and reporting
- Run product feasibility and pre-clinical tests in-house and manage outsourcing to other third-party facilities.
- Write and revise protocols, data collection forms, and reports
- Clearly and efficiently communicate project progress using presentation tools in weekly group meetings
- Monitor/Scan for technologies and manufacturing processes of value to the business
Requirements
- Graduate degree from an accredited college or university in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical, and correlates) required
- 5+ years full-time experience in product development role in the medical device industry
- Prior work history in FDA and/or ISO-regulated medical product development (21 CFR 820 and ISO 13485)
- Experience in planning, conducting and reporting on verification and validation tests
- Experience with design of experiments, test method development, statistical analysis techniques, and data analysis tools
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
product developmentregulatory submissionsrisk managementverification and validationdesign of experimentstest method developmentstatistical analysisdata analysis
Soft skills
communicationcollaborationdocumentation
Certifications
graduate degree in engineering