Manufacturing Engineer II – Shift B

About the role

The Manufacturing Engineer II provides engineering support to production, designing, developing, testing, and implementing processes, tooling, and fixtures for commercial medical devices. The role also sustains production line activities, addressing raw material, process, and equipment issues.

Key responsibilities

• Collaborate with Production to resolve product and process problems and support sustaining activities.
• Identify and lead improvement projects for process, tooling, equipment, and cost reduction.
• Perform functional and destructive testing for process validation and new supplier qualification, documenting results and statistical analysis.
• Participate in new product introduction, develop and maintain FMEAs, Manufacturing Process Instructions, and Device Master Record documents.
• Create and release label files, execute validation protocols, and maintain product configuration documentation.

Required profile

• Bachelor’s degree in engineering with 3‑5 years of experience in a medical device environment.
• Knowledge of Quality System requirements (QSR, FDA, ISO, MDD) and experience with device validation (IQ‑OQ‑PQ).
• Understanding of Lean and Six Sigma concepts and basic statistics (Cpk, hypothesis testing, DOE, Gage R&R).
• Ability to work in a fast‑paced environment, manage multiple priorities, and lift objects up to 25 lb.

Required skills

• SolidWorks for creating solids and drawings.
• Minitab and Excel for statistical analysis.
• Lean manufacturing principles and Six Sigma methodology.
• Good Manufacturing Practices (GMP) and validation procedures.