Sr Design Engineer
On-site · Caledonia, Michigan, United States
Job Summary
Sr Design Engineer to design medical devices, support global revenue growth, acquisitions/migrations, and sustaining engineering. Responsibilities include executing design history file activities, developing and evaluating medical device designs to meet requirements for safe clinical solutions, production, reliability, and cost; providing technical assistance; evaluating proposed changes; ensuring regulatory and customer requirements are met; troubleshooting design issues; conducting engineering/data analysis; managing project schedules/budgets; communicating with leaders; collaborating globally with portfolio managers, clinicians, manufacturers, vendors, and internal teams; mentoring engineers; and onsite in Caledonia, MI with 15% travel. Requirements include a BS in Engineering, 7+ years medical device experience (preferred), PMP preferred, and familiarity with FDA/ISO/MDSAP/IEC standards; strong risk management, design history file management, statistics, and cross-functional collaboration; proficiency with SolidWorks, Minitab, TOPS; and a focus on safe, efficacious, and quality product design.
Required Qualifications
- Bachelor of Science Degree in Engineering or closely related 4-year technical degree is required
- 7+ years of medical device engineering experience preferred
- PMP certification preferred
- Regulated industry experience that includes FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements
- Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
- Experience with IEC 60601 and/or IEC 62304 preferred
- Strong familiarity with Risk Management and FMEA
- Design history file within auditing environment
- Statistical analysis of data
- Project management experience
- Involvement with invention disclosures or patents
- Product costing for design
- SolidWorks, Minitab, TOPS experience preferred
- Excellent MS Office skills
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