Senior Medical Device Manufacturing Engineer

Nextern; Osseo (MN); On-site; USD 130,000 - 165,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND Bday

Lifetime Membership Subsidy and Welll

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Disability (Short-Term & Long-Term)

Taco Thursdays!!!

Job summary

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to lead process development and validation for medical devices in a regulatory-driven environment. You will collaborate with QA, R&D, and production to ensure compliant, high-quality production processes.

The role requires 10+ years in medical device manufacturing, proficiency in CAD tools, and knowledge of SPC and lean manufacturing. Salary ranges reflect senior expertise and location in Minnesota.

Qualifications

• 5+ years of experience in medical device manufacturing engineering.
• Experience with ISO 13485 and FDA regulations is preferred.
• Knowledge of SPC and lean manufacturing.

Responsibilities

• Lead manufacturing process development and validation activities (IQ/OQ/PQ).
• Troubleshoot and optimize manufacturing processes for medical devices.
• Write and maintain SOPs, work instructions, and process specs.

Skills

Process development

Troubleshooting

Documentation

Fixture design

CAPA & CI

Cross-functional collaboration

Education

Bachelor’s degree in Manufacturing, Mechanical, Biomedical Engineering

Tools

SolidWorks

AutoCAD

Job description

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to lead process development and validation for medical devices in a regulatory-driven environment. You will collaborate with QA, R&D, and production to ensure compliant, high-quality production processes.

The role requires 10+ years in medical device manufacturing, proficiency in CAD tools, and knowledge of SPC and lean manufacturing. Salary ranges reflect senior expertise and location in Minnesota.