Role OverviewAs a Manufacturing Engineer II, you will contribute to developing and improving manufacturing processes for orthopedic medical devices. You will execute validation activities, support new product introductions, and drive continuous improvement within a regulated manufacturing environment. In this role, you will develop technical depth in manufacturing while supporting larger projects and cross-functional initiatives.
Responsibilities- Develop, implement, and sustain manufacturing methods, process documentation, and operating procedures for assigned product lines.
- Support new equipment installations and validation activities, including: User Requirement Specifications (URS), Functional Design Specifications (FDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Risk Assessment (VRA).
- Conduct process troubleshooting and data analysis to improve yield, reduce variation, and prevent recurrence of non-conformances.
- Partner with cross-functional teams (Quality, NPD, Operations, and Maintenance) to optimize manufacturability and compliance.
- Support continuous improvement and lead cost-reduction initiatives.
- Develop and maintain process documentation including work instructions, routers, and validation reports.
- Assist in developing Process Maps, pFMEAs, MSA plans, and control plans for process risk analysis.
- Contribute to the introduction and transfer of new products or processes into manufacturing.
- Perform other duties as assigned by the Manufacturing Engineering Manager or Senior Engineer.
Education• Bachelor of Science in Engineering required
• Master of Science in Engineering desired
Experience- 2-4 years of manufacturing engineering experience in a regulated industry; medical device preferred.
- Experience with CNC machining, metal finishing (e.g., bead blast, grit blast, polishing), or additive manufacturing preferred.
- Familiarity with validation activities (URS, FDS, IQ, OQ, PQ, VRA) required.
- Working knowledge of GD&T and mechanical drawing interpretation.
- Knowledge of materials commonly used in orthopedic implants (Titanium, Cobalt Chrome, Stainless Steel, medical-grade plastics).
- Proficiency with CAD tools (Siemens NX) preferred.
Physical DemandsStanding and walking in production areas for extended periods.
Lifting objects up to 50 lbs occasionally.
Use of personal protective equipment (PPE) as required.
TravelLess than 10% domestic and/or international travel for equipment supplier visits, training, or project support.
