Manufacturing Engineer II

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. 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 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. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it's our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it's our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We're a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.