Engineer 2, Sustaining, R&D
On-site · Wyomissing, Pennsylvania, United States
Job Summary
Engineer 2, Sustaining in Vascular & Emergency Medicine: responsible for lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency. Analyze design changes, perform verification and validation activities, support design transfer, risk management (DFMEA/UFMEA, CAPA), and maintain design history files and device master records with ISO 13485 and FDA 21 CFR 820 alignment. Collaborate cross-functionally with R&D, quality, regulatory, manufacturing, and clinical teams; develop test protocols, execute tests, and analyze results; support process validation (IQ/OQ/PQ) and manufacturing scalability. Requires BS in Engineering and a minimum of 2 years of related experience; travel up to 10% to support clinical interactions and manufacturing activities.
Required Qualifications
- BS in Engineering or equivalent technical discipline
- Minimum of 2 years of experience in medical device design/manufacturing or related regulated industry
- Strong documentation skills
- CAD experience (SolidWorks)
- Familiarity with ISO 13485, FDA 21 CFR 820
- Understanding of R&D, quality, regulatory, manufacturing collaboration
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