KH
Manufacturing Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Manager or above
- 22 hours ago
- Regulatory Compliance
- Windchill
- GMP
22 hours ago
We are seeking an experienced Manufacturing Engineer to lead technical Life Cycle Management (LCM) projects for orthopedic medical devices, particularly metal implants. The role involves managing external manufacturing partners, ensuring regulatory compliance, and coordinating cross-functional teams to deliver technical projects successfully.
Roles and Responsibilities:
- Lead LCM projects for existing medical device products and external manufacturing partners.
- Manage project scope, timelines, technical feasibility, risks, and deliverables.
- Coordinate with Quality, R&D, Regulatory Affairs, Supply Chain, and Operations teams.
- Manage documentation, change controls, and project activities using PLM tools such as Windchill.
- Review engineering drawings, manufacturing processes, IQ/OQ/PQ protocols, and validation reports.
- Ensure compliance with FDA, MDD, MDR, and GMP requirements.
- Coordinate asset decommissioning and disposal activities.
Education and Experience:
- Degree or equivalent experience in Manufacturing Engineering, preferably orthopedic medical devices and metal implants.
- Minimum 5 years of hands-on medical device quality systems experience.
- Knowledge of FDA regulations, MDD, MDR, and GMP requirements.
- Experience leading technical projects and cross-functional teams.
- Experience working with external manufacturing partners and suppliers.
- Strong communication, problem-solving, prioritization, and project management skills.
Manufacturing Engineer · Katalyst Healthcares & Life Sciences