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Smith+Neo is seeking a Manufacturing Engineer II to advance process improvement, validation activities, and new product introductions within a highly regulated manufacturing environment. You will work with cross-functional teams to drive manufacturability and operational excellence, contributing to yield improvements and cost reduction.
The role requires a Bachelor's in Engineering with 2–4 years of manufacturing experience in a regulated industry (medical devices preferred); CAD tooling with
Life. Unlimited. At Smith+Neo we design and manufacture technology that takes the limits off living. Join Smith+Neo and play a key role in advancing the manufacturing of orthopedic medical devices that help improve patients' lives around the world. As a Manufacturing Engineer II, you will contribute to process improvement, validation activities, new product introductions, and operational excellence within a highly regulated manufacturing environment. This is an exciting opportunity to deepen your technical expertise while collaborating with cross functional teams to deliver innovative solutions and drive meaningful impact.
Develop, implement, and sustain manufacturing methods, process documentation, and operating procedures for assigned product lines. Support equipment installation and validation activities including URS, FDS, IQ, OQ, PQ, and validation report approvals. Analyze manufacturing processes, troubleshoot issues, and drive improvements to increase yield, reduce variation, and prevent nonconformances. Partner with Quality, Operations, New Product Development, and Maintenance teams to improve manufacturability and compliance. Lead and support continuous improvement and cost reduction initiatives. Create and maintain technical documentation, including work instructions, validation reports, process maps, pFMEAs, MSA plans, and control plans. Support the transfer and introduction of new products and manufacturing processes.
Bachelor's degree in Engineering required. Master's degree preferred. 2 to 4 years of manufacturing engineering experience within a regulated industry, with medical device experience preferred. Experience supporting validation activities including URS, FDS, IQ, OQ, PQ, and VRA. Knowledge of GD&T, mechanical drawing interpretation, and manufacturing processes such as CNC machining, metal finishing, or additive manufacturing. Familiarity with materials used in orthopedic implants and proficiency with CAD tools such as Siemens NX is preferred. Strong analytical, problem solving, and cross functional collaboration skills.
You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website.
401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement.
Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day.
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program.
Hybrid Work Model (for most professional roles).
Hands On, Team Customized, Mentorship.
Discounts on fitness clubs, travel and more!
Smith+Neo 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+Neo 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+Neo 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.