layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Manufacturing Engineer - Medical Device
Nextern
Maple Grove, MN, US
Source: Nextern careers · View original posting
- Employment
- full time
Employer job description
From Nextern's posting. “We” and “our” refer to the employer.
We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved: manufacturing methods, systems and processes to produce a high-quality product.
Requirements
- DUTIES AND RESPONSIBILITIES: Process Development Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Process Support & Optimization: Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.
- Technical Documentation: Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards.