Senior Advanced Manufacturing Engineer

Smith+Nephew•Maple Plain, MN

1d•$96,750 - $145,000•Hybrid

About The Position

Smith+Nephew is hiring a Senior Advanced Manufacturing Engineer to join its Operations team in Maple Plain, Minnesota. The role supports manufacturing capabilities for high-quality Class I and Class II medical devices, from New Product Introduction through full commercialization. The engineer leads process development, validation, scale-up, and continuous improvement in collaboration with R&D, Quality, Supply Chain, Commercial, and Production. The position develops and implements scalable, cost-effective manufacturing processes, fixtures, and equipment; leads process and equipment development as products advance into commercialization; and qualifies and validates processes and equipment. It also owns ongoing manufacturing performance and improvement, supports design changes and design for manufacturability, and leads initiatives to improve capacity, yield, efficiency, and cost of goods sold. The role provides hands-on production support, develops processes and automation, guides and trains colleagues and product builders, and ensures engineering work is documented in accordance with company procedures and regulatory requirements. The position requires a bachelor's degree in Engineering and at least five years of related experience, or an equivalent combination of education and relevant work experience. Candidates should have experience taking equipment and fixtures from concept through production, manufacturing problem-solving and improvement methods, and work in medical devices or another regulated industry. CAD experience, preferably SolidWorks, and statistical software experience, preferably Minitab, are also requested. The role involves the ability to lift up to 30 pounds and wear cleanroom clothing when working in a cleanroom. Applicants must already be authorized to work in the United States and must not need current or future employer sponsorship to maintain that authorization.

Requirements

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.
Practical knowledge of manufacturing problem-solving and process improvement methods such as DMAIC.
Experience in medical devices or another regulated industry.
Ability to work effectively across technical and cross-functional teams in a fast-paced environment.
Experience with CAD software; SolidWorks is preferred.
Experience with statistical software; Minitab is preferred.
Proactive, detail-focused approach with strong communication, prioritization, and problem-solving skills.
Ability to work with minimal supervision.
Ability to lift up to 30 pounds and wear cleanroom clothing when working in a cleanroom environment.
Currently authorized to work in the United States without requiring Smith+Nephew sponsorship now or in the future.

Nice To Haves

Experience with SolidWorks.
Experience with Minitab.

Responsibilities

Develop, specify, and implement manufacturing processes, fixtures, and equipment for 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 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, identify and resolve production line issues, and assess potentially discrepant product.
Develop new processes, procedures, tooling, and automation, and serve as a key point of contact for assigned areas.
Support and guide other manufacturing engineers, contractors, and less experienced engineers as needed.
Train product builders on manufacturing processes and the safe use of equipment and fixtures.
Document engineering activities in accordance with company procedures, regulatory requirements, and sound engineering practices.