NPI MFG Engineer (Medical Devices)

Job Summary

- Lead process risk assessments (PFMEA) with cross-functional teams in engineering, quality, and manufacturing.

- 100% onsite role

- Apply design-for-manufacturing (DFM) and design-for-assembly (DFA) principles to optimize product introduction.

- Develop and refine assembly and testing methods that meet critical quality requirements.

- Perform validation and verification of test methods to ensure reliability and compliance.

- Support new product introduction (NPI) and process development for capital equipment and disposable products.

- Bachelor’s degree required with experience in FDA/ISO-regulated medical device manufacturing.

Job Type: Contract

Pay: $55.00 - $75.00 per hour

Expected hours: 40 per week

Benefits:

- 401(k)

- Health insurance

Experience:

- PFMEA (Process Failure Mode and Effects Analysis): 5 years (Required)

- Injection Molding: 5 years (Required)

- IQ OQ and PQ protocols: 5 years (Required)

- Medical Device : 5 years (Preferred)

- Test Method Validation and Verification (TMV, V&V): 5 years (Required)

- New Product Introduction: 5 years (Required)

Work Location: On the road