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Summary
About the Role
About You
- Bachelor's degree in engineering, manufacturing, operations management, or related field.
- Minimum of 5-7 years of experience in operations management, with at least 3 years in a medical device manufacturing environment or regulated industry.
- Proficiency in ERP systems (e.g., SAP, Oracle, Infor) and MS Office Suite.
- In-depth understanding of FDA regulations, ISO 13485, and GMP guidelines.
- Proven ability to lead and manage cross-functional teams.
- Strong analytical and problem-solving skills.
- Experience in medical device sterilization processes (e.g., EO, gamma, autoclave).
- Familiarity with FDA design controls and risk management processes.
- Strong understanding of the supply chain and logistics within the medical device manufacturing industry.
- Experience working in a contract manufacturing organization (CMO).
Improving Lives through Medical Device Innovation. At ATL Technology, we are the trusted partner of choice for leading medical device OEMs worldwide. With over 30 years of expertise, we excel in designing, developing, and manufacturing innovative medical devices that improve and save lives. Our commitment to engineering excellence and unwavering dedication to quality drive us to deliver cutting-edge solutions across various medical fields. From electrosurgical instruments and camera-based imaging devices to high-density interconnect technologies, we offer a wide range of specialized products and services. Our vertically integrated capabilities empower us to collaborate with OEMs at any stage of development, from concept to mass production. We pride ourselves on fostering innovation through robust partnerships and comprehensive support, ensuring our customers' success in an ever-evolving healthcare landscape. At ATL Technology, we understand that it's not just about technology; it's about the people behind it who drive real change in healthcare. Join us in our mission to protect and enhance lives through groundbreaking medical device innovation. Innovation. Expertise. Excellence. ATL Technology.