Manufacturing Engineer

About the role

We are seeking a hands‑on Manufacturing Engineer to evaluate, optimize, and document in‑process and incoming testing jigs, ensuring precise accuracy and repeatability for novel medical device manufacturing. The role executes test method validations, supports equipment qualifications (IQ/OQ/PQ) at contract manufacturing sites, and drives seamless design transfer to contract manufacturers within a regulated GMP environment.

Key Responsibilities

• Evaluate, operate, and document mechanical testing fixtures/jigs; conduct Gage R&R studies to verify measurement accuracy and repeatability.
• Execute Test Method Development (TMD) and Test Method Validation (TMV); support IQ/OQ/PQ activities and design transfer to contract manufacturing facilities.
• Perform testing on disposable catheter and camera prototypes; manage supply‑chain logistics, inventory flow, and BOM structures for R&D/manufacturing components.
• Review engineering drawings to ensure Design for Manufacturability (DFM) compliance; manage Engineering Change Requests (ECRs), process documentation, and evaluation reports in a QMS using FMEA principles.
• Partner with Engineering and Quality teams to capture design outputs and ensure strict adherence to GMP standards.

Qualifications & Core Competencies

• 2–5 years of experience in medical device manufacturing or R&D engineering within regulated GMP environments.
• Hands‑on experience with mechanical testing jigs/fixtures, Gage R&R studies, and disposable manufacturing processes.
• Working knowledge of injection molding, polymers, catheter/camera assembly, metal processing, and medical device mechanical design.
• Proficiency in SolidWorks CAD, BOM management, ECR execution, and Quality Management Systems (QMS).
• Proven track record in lab inventory management, vendor coordination, FMEA, and IQ/OQ/PQ execution.
• Strong technical/hands‑on orientation, GMP compliance focus, fixture testing expertise, TMV execution, and contract manufacturing design transfer experience.

Pay

Target pay rate: $55/hr (contract). Target salary after conversion to full‑time: $100,000 – $115,000.

Schedule

7 hours per shift.