Manufacturing Engineer II (Maple Plain, MN)

Reposted 10 Days Ago
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Maple Plain, MN, USA
In-Office
78K-117K Annually
Mid level
Healthtech • Biotech
The Role
Lead development, validation, and scale-up of manufacturing processes for a soft-tissue repair device. Drive DFM, tooling/equipment development, partner with R&D/Quality/Supply Chain, perform root-cause analysis, and support process validations and documentation per ISO 13485/FDA QSR.
Summary Generated by Built In

Manufacturing Engineer II (Maple Plain, MN)

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

As part of the Integrity Orthopaedics Group, you will join as a Manufacturing Engineer and own the development, validation, and scale-up of manufacturing processes for our innovative surgical device — directly contributing to product quality, efficiency, and patient outcomes. Integrity Orthopaedics is a fast-growing medical device company transforming soft tissue repair with a patented, FDA-cleared system designed to improve surgical fixation and long-term healing in rotator cuff repairs. Backed by significant Series B funding and a strong clinical foundation, we’re scaling operations to support broader commercial launch and production excellence.

What will you be doing?

  • Lead development and optimization of manufacturing processes for soft-tissue repair device systems
  • Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production
  • Develop and validate equipment, fixtures, and tooling for assembly and inspection
  • Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output
  • Execute structured root-cause analysis and corrective actions for production challenges
  • Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR
     

What will you need to be successful?

Education:

  • BS in Engineering (Mechanical/Manufacturing/Industrial or related)
     

Experience:

  • 2-5 years engineering experience in manufacturing or process engineering
  • Hands-on experience scaling products from prototype to production
  • Familiarity with regulated medical device environments
     

Knowledge:

  • Understanding of manufacturing metrics and continuous improvement tools (e.g., lean, DMAIC)
  • Proficiency in CAD software
     

Competences:

  • Fixture/tooling design and implementation skills
  • Strong problem-solving skills
  • Executing process development and validations with guidance

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!  

Compensation

The anticipated base compensation range for this position is $74,250.00 - 111,500.00 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.  

Benefits

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.

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. 

 

Top Skills

Cad
Dmaic
Fda Qsr
Iso 13485
Lean
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The Company
Andover, MA
15,318 Employees

What We Do

Smith+Nephew 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+Nephew 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. Please note: not all products referred to may be approved for use or available in all markets.

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