Job Title: Manufacturing LCM Engineer – Orthopedic Medical Devices
Location: West Lancaster, PA
Must-Have Technical/Functional Skills
- A degree-level qualification or equivalent experience in manufacturing engineering in orthopedics (metal implants), with the ability to lead lifecycle management technical projects with external manufacturing partners and suppliers.
- Minimum 5 years of hands-on experience in medical device quality systems across various operational quality system tasks.
- Knowledge of medical device FDA, MDD, and MDR GMP requirements.
- Experience leading cross-functional teams is required.
- The candidate must be an effective communicator, capable of working with external partners and internal cross-functional teams, facilitating discussions, and navigating challenges. Ideally, this individual would serve as both a project lead and technical lead.
Roles & Responsibilities
- Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners, ensuring projects are completed on schedule, within scope, and in accordance with business objectives.
- Provide technical oversight and project leadership for external manufacturing partners. Assess and develop project scope, business cases, and technical feasibility, and ensure effective implementation in alignment with business, quality, and regulatory requirements.
- Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities.
- Partner with and lead cross-functional teams, including Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations, to execute supply chain priorities, change requests, and project deliverables.
- Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operational risks, and maintain customer service commitments.
- Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems.
- Manage asset decommissioning and disposal requests with external manufacturing partners and coordinate the required disposition activities with internal business partners.
Generic Managerial Skills, If Any
- Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English.
- Ability to effectively prioritize and manage multiple activities and responsibilities.
- Ability to function in a team environment and deliver on team objectives.
- Ability to make decisions and solve problems while exhibiting situational judgment.
- Experience leading projects and cross-functional teams is required.
Role Description
Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners, ensuring projects are completed on schedule, within scope, and in accordance with business objectives. Provide technical oversight and project leadership for external manufacturing partners. Assess and develop project scope, business cases, and technical feasibility, and ensure effective implementation in alignment with business, quality, and regulatory requirements. Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities. Partner with and lead cross-functional teams, including Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations, to execute supply chain priorities, change requests, and project deliverables. Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operational risks, and maintain customer service commitments. Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems. Manage asset decommissioning and disposal requests with external manufacturing partners and coordinate the required disposition activities with internal business partners.
Essential Skills: Manufacturing LCM Engineer
Skills: EIS: Manufacturing Engineering Support
Experience Required: 6–8 years
