Senior Medical Device Manufacturing Engineer - Process

Nextern; Maple Grove (MN); On-site; USD 100,000 - 140,000; 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 Boss

Birthday Holiday

Lifetime Membership Subsidy and Wellne

Life Insurance (Basic, Voluntary & AD&

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays

Job summary

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic team.

You will lead process development and validation, create procedures, and collaborate with QA, R&D, and production to ensure compliant, high-quality manufacturing.

The ideal candidate has 5+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), SPC/lean expertise, and ISO 13485 knowledge.

Qualifications

• 5+ years of experience in medical device manufacturing engineering.
• Proficiency in CAD software (SolidWorks, AutoCAD, or similar).
• Knowledge of statistical process control (SPC) and lean manufacturing; understanding of medical device validation processes (IQ, OQ, PQ).
• Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
• Experience with metal-based components, assemblies, and processing.

Responsibilities

• Lead process development and validation activities: IQ, OQ, PQ reports, BOM, assembly instructions, and manufacturing procedures.
• Troubleshoot and optimize manufacturing processes for medical devices while maintaining quality.
• Write, review, and maintain SOPs, work instructions, and process specifications in FDA/ISO 13485 compliance.
• Design, develop, and implement fixtures, tooling, and equipment for production with design control compliance.
• Lead root cause analysis, CAPA, and drive continuous improvement to enhance quality and efficiency.
• Collaborate with Quality Assurance, R&D, and Production teams for smooth product launches.

Skills

Statistical process control

Lean manufacturing

ISO 13485 knowledge

IQ/OQ/PQ validation understanding

Education

Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field

Tools

SolidWorks

AutoCAD

Job description

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic team.

You will lead process development and validation, create procedures, and collaborate with QA, R&D, and production to ensure compliant, high-quality manufacturing.

The ideal candidate has 5+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), SPC/lean expertise, and ISO 13485 knowledge.