Senior Medical Device Process & Scale-Up Engineer

Smith & Nephew; Minnesota; Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Discounted Stock Options

Medical, Dental, Vision

Job summary

Smith+Nephew in Maple Plain, Minnesota, seeks a Senior Advanced Manufacturing Engineer to lead process development, validation, scale-up and continuous improvement for Class I/II medical devices from NPI to full commercialization. You will collaborate across R&D, Quality, Supply Chain and Production to drive DMAIC-based improvements and ensure compliant documentation.

Role involves mentoring engineers, solving production issues, and driving safe, efficient manufacturing operations in a regulated

Qualifications

• Bachelor’s degree in Engineering with 5+ years of related experience.
• Experience taking equipment from concept through production using problem solving and DMAIC methods.
• Experience in medical devices or regulated industries with cross-functional collaboration.
• Proficiency in CAD software (SolidWorks) and statistical tools (Minitab).

Responsibilities

• Develop and implement manufacturing processes, fixtures and equipment for scalable production.
• Lead process development, validation, and scale-up to full commercialization.
• Qualify and validate processes, fixtures and equipment with IQ/OQ/PQ.
• Provide hands-on support and train other engineers and product builders.

Skills

Experience

Problem solving

DMAIC

Education

Bachelors in Engineering

Tools

SolidWorks

Minitab

Job description

Smith+Nephew in Maple Plain, Minnesota, seeks a Senior Advanced Manufacturing Engineer to lead process development, validation, scale-up and continuous improvement for Class I/II medical devices from NPI to full commercialization. You will collaborate across R&D, Quality, Supply Chain and Production to drive DMAIC-based improvements and ensure compliant documentation.

Role involves mentoring engineers, solving production issues, and driving safe, efficient manufacturing operations in a regulated