Senior MedTech Manufacturing Engineer
Nextern
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Benefits offered by this job
Job summary
NPX Medical, a division of Nextern, seeks an experienced Manufacturing Engineer in Minnesota to lead process development and validation for medical devices. You will optimize production, draft SOPs, and drive CAPA initiatives while collaborating with QA, R&D and Production for successful launches.
The role requires 10+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), and strong knowledge of SPC, lean methods, and IQ/OQ/PQ within ISO 13485 environments.
Qualifications
- Degree in a relevant engineering field is required.
- 10+ years of medical device manufacturing experience.
- Proficiency with CAD software (SolidWorks/AutoCAD).
- Familiarity with SPC and lean manufacturing; IQ/OQ/PQ knowledge.
- ISO 13485:2016 quality management system understanding.
- Experience with metal components and assembly processing.
Responsibilities
- Lead manufacturing process development and validation activities (IQ/OQ/PQ).
- Troubleshoot and optimize manufacturing processes for devices.
- Develop and maintain SOPs, work instructions, and process specs.
- Design fixtures, tooling, and equipment for production.
- Lead CAPA and continuous improvement initiatives.
- Collaborate with QA, R&D, and Production for launches.
Skills
Education
Tools
Job description
NPX Medical, a division of Nextern, seeks an experienced Manufacturing Engineer in Minnesota to lead process development and validation for medical devices. You will optimize production, draft SOPs, and drive CAPA initiatives while collaborating with QA, R&D and Production for successful launches.
The role requires 10+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), and strong knowledge of SPC, lean methods, and IQ/OQ/PQ within ISO 13485 environments.
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