Lcm Engineer

LCM Engineer
West Chester, PA
Hire Type: fulltime

Salary Range: $90,000-$100,000 a year

Orthopaedic metal-implant manufacturing engineering
Manufacturing LCM project leadership
External manufacturing supplier technical oversight
Windchill
IQ/OQ/PQ
Manufacturing process/equipment qualification and validation
Asset decommissioning/disposal activities

Must Have Technical/Functional Skills
A degree level or similar qualification experience in manufacturing engineering in orthopedics (metal implants) that can lead lifecycle management technical projects with our external manufacturing partners and suppliers.
Minimum 5 years of hands-on experience in medical device quality systems in various operational tasks of quality systems
Knowledgeable in medical device FDA, MDD and MDR GMP requirements.
Experience leading cross-functional teams is required
The candidate will need to be an effective communicator, capable of working with both external partners with external partners and internal cross functions, facilitating discussions, and navigating through 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 case 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 with 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 operations 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 disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.