Senior Advanced Manufacturing Engineer

Smith & Nephew, Inc.; United States; Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

401k Matching Program

Discounted Stock Options

Tuition Reimbursement

Medical, Dental, Vision

Hybrid Work Model

Paid Holidays

Parental Leave

Flexible Personal/Vacation Time Off

Wellness offerings

Job summary

Smith+ Nephew in Maple Plain, Minnesota, seeks a manufacturing engineer to lead process development, validation, scale-up and continuous improvement for Class I/II medical devices.

You will collaborate across R&D, Quality, Supply Chain, and Production to drive design for manufacturability and tooling needs while supporting cross-functional teams in a fast-paced environment. A strong emphasis on problem solving and hands-on execution is required.

Qualifications

• Bachelor’s degree in Engineering with 5+ years of related experience.
• Experience taking equipment and fixtures from concept through production.
• Experience in medical devices or regulated industries.
• SolidWorks CAD and statistical software (Minitab) experience.
• Ability to lift up to 30 pounds and work in cleanroom environments.

Responsibilities

• Develop, specify and implement manufacturing processes, fixtures and equipment for scalable production.
• Lead process and equipment development from NPI into full commercialization.
• Qualify and validate processes, fixtures and equipment with IQ, OQ and PQ.
• Own ongoing performance and continuous improvement of processes, tooling and manufacturing equipment.
• Partner with R&D to support design changes and manufacturability.
• Lead scale up and process improvement focusing on capacity, yield and cost of goods sold.
• Provide hands-on manufacturing support and resolve production line issues.
• Train product builders on processes and safe use of equipment and fixtures.

Skills

Problem solving

Communication

Prioritization

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Minitab

Job description

#

Life. Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living.

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
• - Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• - Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• - Flexibility: Hybrid Work Model (For most professional roles)
• - Training: Hands-On, Team-Customized, Mentorship
• - Extra Perks: 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+ 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.

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