Senior Advanced Manufacturing Engineer

Life. Unlimited. At Smith+Neu Join our Operations team in Maple Plain, Minnesota, and help shape manufacturing capabilities that support high quality medical devices from New Product Introduction through full commercialization. This is an opportunity for an action oriented manufacturing engineer to lead process development, validation, scale up and continuous improvement while collaborating across R&D, Quality, Supply Chain, Commercial and Production.

Develop, specify and implement manufacturing processes, fixtures and equipment for the scalable, cost effective production of high quality Class I and Class II medical devices. Lead manufacturing process and equipment development as products progress from New Product Introduction into full commercialization. Qualify and validate manufacturing processes, fixtures and equipment, partnering with Design, Quality and external partners on IQ, OQ and PQ activities.

Own the ongoing performance and continuous improvement of manufacturing processes, validations, equipment and tooling for medical device assembly. Partner with R&D to support design changes, drive design for manufacturability and define tooling and equipment requirements. Lead scale up and process improvement initiatives focused on manufacturing capacity, process yield, operational efficiency and cost of goods sold. Provide hands on manufacturing support, identifying and resolving production line issues and assessing potentially discrepant product.

Apply technical expertise to develop new processes, procedures, tooling and automation while serving as a key point of contact for assigned areas. Support and guide other manufacturing engineers, contractors and less experienced engineers as needed, while effectively training product builders on manufacturing processes and the safe use of equipment and fixtures. Ensure engineering activities are appropriately documented in accordance with company procedures, regulatory requirements and sound engineering practices.

Bachelor’s degree in Engineering with 5 or more years of related experience, or an equivalent combination of education and relevant work experience. Demonstrated experience taking equipment and fixtures from concept through production, along with practical knowledge of manufacturing problem solving and process improvement methods such as DMAIC. Experience with in medical devices or another regulated industry, with the ability to work effectively across technical and cross functional teams in a fast paced environment.

Experience with CAD software, preferably Solid Works, and statistical software, preferably Minitab. A proactive, detail focused approach with strong communication, prioritization and problem solving skills, plus the ability to work with minimal supervision. The role also requires the ability to lift up to 30 pounds and wear clean room clothing when working in a cleanroom environment.

Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization.

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 Options, Tuition Reimbursement
• Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Medical, Dental, Vision,…