Senior Advanced Manufacturing Engineer

Smith & Nephew; Town of Maple Plain (WI); Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Hybrid Work Model

Wellness benefits

Job summary

Smith+Neu in Maple Plain, Minnesota, is seeking a manufacturing engineer to lead process development, validation, scale‑up and continuous improvement for Class I and II medical devices. You will own manufacturing processes, fixtures and equipment from New Product Introduction into full commercialization, collaborating across R&D, Quality, Supply Chain and Production.

The role requires a Bachelor’s degree in Engineering with 5+ years’ related experience, experience taking equipment from concept

Qualifications

• Bachelor’s degree in Engineering with 5+ years of related experience.
• Experience taking equipment from concept to production.
• Experience in medical devices or regulated industry.
• Ability to work across cross-functional teams in a fast-paced environment.

Responsibilities

• Develop and implement manufacturing processes for Class I and II devices.
• Lead scale-up, validation (IQ/OQ/PQ) activities.
• Provide hands-on manufacturing support and issue resolution.
• Train and mentor other engineers and contractors.

Skills

SolidWorks

Minitab

DMAIC

Manufacturing engineering

Cross-functional teamwork

Problem solving

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Minitab

Job description

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.

What will you be doing?

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.

What will you need to be successful?

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 within 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 SolidWorks, 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 (https://www.smith-nephew.com/).

Your Future:

• 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, 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!

The anticipated base compensation range for this position is $96,750.00 - 145,000.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith+Neu 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.

Smith+Neu 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+Neu 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.