Senior Medical Device Process Engineer

Nextern; Osseo (MN); Sur place; USD 100 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health Care Plan

Retirement Plan with Company Match

Paid Time Off

Birthday Holiday

Lifetime Membership Subsidy

Life Insurance

Family Leave

Short-Term Disability

Long-Term Disability

Taco Thursdays

Résumé du poste

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer in Minnesota to drive process development and validation in medical device production. You will manage multiple projects while ensuring adherence to FDA and ISO 13485 standards.

The role requires 5+ years in medical device manufacturing, CAD proficiency, and strong problem-solving abilities to improve methods, systems, and efficiency across cross-functional teams.

Qualifications

• Bachelor’s degree in a relevant engineering field.
• 5+ years of experience in medical device manufacturing engineering.
• Proficiency in CAD software such as SolidWorks or AutoCAD.
• Knowledge of SPC and lean manufacturing and medical device validation (IQ/OQ/PQ).
• Thorough understanding of ISO 13485:2016 Medical Device QMS.

Responsabilités

• Lead manufacturing process development and validation activities (IQ/OQ/PQ) and related docs.
• Troubleshoot and optimize manufacturing processes for medical devices.
• Write and maintain SOPs, work instructions, and process specs per FDA and ISO 13485.
• Design, develop, and implement fixtures and tooling for production.
• Lead root cause analysis and CAPA, driving continuous improvement.
• Collaborate with QA, R&D and Production for seamless launches.

Connaissances

Cross-functional collaboration

Troubleshooting

Continuous improvement

Formation

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

Outils

CAD software (SolidWorks, AutoCAD, or similar)

Description du poste

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer in Minnesota to drive process development and validation in medical device production. You will manage multiple projects while ensuring adherence to FDA and ISO 13485 standards.

The role requires 5+ years in medical device manufacturing, CAD proficiency, and strong problem-solving abilities to improve methods, systems, and efficiency across cross-functional teams.