Product Development Engineer
Coloplast
full-time
Posted on:
Location Type: Office
Location: Minneapolis • Minnesota • United States
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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 & Tools
product developmentregulatory submissionsrisk managementverification and validationdesign of experimentstest method developmentstatistical analysisdata analysis
Soft Skills
communicationcollaborationdocumentation
Certifications
graduate degree in engineering