Engineer II – Labeling

🕒 July 10

🏄 California, Hawaii, +3 more states – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1970

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Post-IPO Debt on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

📋 Description

• Plans, schedules, conducts, and coordinates detailed phases of the labeling process • Prepares, creates, and controls labels and Instructions for Use according to procedure • Tracks and maintains labeling documents using process tools • Reviews labeling documents to ensure accuracy • Initiates and/or implements Change Control Requests • Performs upload and maintain applicable UDI databases • Investigate, contribute and support new labeling process technologies • Communicate with internal and external customers regarding ongoing labeling updates • Collaborate with cross-functional teams to ensure labeling deliverables are on-track

🎯 Requirements

• Bachelor’s degree in a related field or 3+ years of experience of GMP, FDA, Change Control process • Strong proficiency with Microsoft Office • Strong proficiency with Adobe InDesign • Strong proficiency with Adobe Illustrator • Strong understanding of Regulatory labeling landscape.

🏖️ Benefits

• Health insurance • 401(k) with company match • 80 hours of holidays per year • Paid time off • Adoption benefits • Parental leave after one year • Supplemental life insurance • Critical illness insurance • Hospital indemnity and accident insurance