Senior Manufacturing Engineer (Maple Plain, MN)

Smith+Nephew•Maple Plain, MN

5d•Hybrid

About The Position

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 Process Development/Advanced 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 cross-functional technical initiatives and major scale-up projects Drive continuous improvement projects that significantly impact throughput and cost Influence design decisions for manufacturability and production reliability Act as a technical authority on manufacturing processes and equipment Mentor and guide Engineer II/III level contributors What will you need to be successful? Education: BS in Engineering (Mechanical/Manufacturing/Industrial or related) Experience: 5+ years in manufacturing or process engineering, preferably in medical device or regulated manufacturing industries Proven track record of owning complex process validations and scale-ups SPC/DOE experience Exposure to cleanroom or aseptic manufacturing environments Knowledge: Knowledge of DFMEA/PFMEA and quality system requirements (ISO 13485, FDA QSR) Proficiency in CAD software (SolidWorks preferred) Competences: Strong leadership, communication, and project management skills Other requirements: Ability to lift up to 30 pounds Must be able to wear clean room clothing and work in a cleanroom environment as needed. 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 $101,500.00 - 152,250.00 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. 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.

Requirements

BS in Engineering (Mechanical/Manufacturing/Industrial or related)
5+ years in manufacturing or process engineering, preferably in medical device or regulated manufacturing industries
Proven track record of owning complex process validations and scale-ups
SPC/DOE experience
Exposure to cleanroom or aseptic manufacturing environments
Knowledge of DFMEA/PFMEA and quality system requirements (ISO 13485, FDA QSR)
Proficiency in CAD software (SolidWorks preferred)
Strong leadership, communication, and project management skills
Ability to lift up to 30 pounds
Must be able to wear clean room clothing and work in a cleanroom environment as needed.

Responsibilities

Lead cross-functional technical initiatives and major scale-up projects
Drive continuous improvement projects that significantly impact throughput and cost
Influence design decisions for manufacturability and production reliability
Act as a technical authority on manufacturing processes and equipment
Mentor and guide Engineer II/III level contributors