Senior Manufacturing Engineer (Maple Plain, MN)
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Requirements
- 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!
Benefits
Additional Information
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As part of the Integrity Orthopaedics team , Smith+Nephew's latest acquisition , you will join as a Process Development/Senior 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 transformed soft tissue repair with a patented, FDA-cleared system designed to improve surgical fixation and long-term healing in rotator cuff repair. Now part of Smith+Nephew , we are expanding production to support a broader commercial launch and drive operational excellence across the organization. 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)
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