Manufacturing Engineer II

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

Requirements

• 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 Demands
• Standing and walking in production areas for extended periods.
• Lifting objects up to 50 lbs occasionally.
• Use of personal protective equipment (PPE) as required.
• Travel
• Less than 10% domestic and/or international travel for equipment supplier visits, training, or project support.
• Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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Additional Information

Role Overview As 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.

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