Manufacturing LCM Engineer

Job Description: Manufacturing LCM Engineer

Job Details

• Job Title: Manufacturing LCM Engineer

• Location: West Lancaster, Pennsylvania

• Duration: 6 months

• Experience Required: 6–8 years

• Essential Skill: Manufacturing Lifecycle Management (LCM) Engineering

• Skill Category: EIS – Manufacturing Engineering Support

Must-Have Technical/Functional Skills

• Degree-level qualification or equivalent experience in Manufacturing Engineering, preferably in orthopedics and metal implants.

• Minimum 5 years of hands-on experience with medical device quality systems and quality-related operational activities.

• Strong knowledge of medical device FDA, MDD, MDR, and GMP requirements.

• Experience leading cross-functional teams and technical projects.

• Experience working with external manufacturing partners and suppliers.

• Strong technical and project leadership capabilities.

• Excellent communication, collaboration, and problem-solving skills.

• Ability to manage multiple projects and priorities effectively.

Roles and Responsibilities

• Lead and execute technical Lifecycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners.

• Ensure projects are completed on schedule, within scope, and aligned with business objectives.

• Provide technical oversight and project leadership to external manufacturing partners.

• Define project scope, develop business cases, assess technical feasibility, and ensure successful implementation.

• Ensure project execution complies with business, quality, and regulatory requirements.

• Use Product Lifecycle Management (PLM) systems, including Windchill, to manage technical documentation, change controls, and project activities.

• Collaborate with cross-functional teams, including:

  • Quality Assurance (QA)

  • Research and Development (R&D)

  • Regulatory Affairs

  • Sourcing

  • Supply Planning

  • Operations

• Lead and coordinate supply chain priorities, change requests, and project deliverables.

• Facilitate communication between internal stakeholders and external manufacturing partners.

• Proactively resolve technical and operational issues, mitigate risks, and maintain customer service commitments.

• Review and approve technical documentation, including:

  • Engineering drawings

  • Manufacturing process documentation

  • Installation Qualification (IQ) protocols

  • Operational Qualification (OQ) protocols

  • Performance Qualification (PQ) protocols

  • Qualification reports

  • Process and equipment validation documentation

• Support validation activities for new and existing processes, equipment, and systems.

• Manage asset decommissioning and disposal requests with external manufacturing partners.

• Coordinate asset disposition activities with internal business stakeholders.

• Ensure lifecycle management projects meet quality, regulatory, technical, and operational requirements.

Generic Managerial Skills

• Excellent written, verbal, and interpersonal communication skills in English.

• Strong project management and cross-functional team leadership experience.

• Ability to prioritize and manage multiple activities and responsibilities.

• Ability to work effectively in a team-oriented environment.

• Strong decision-making and problem-solving skills.

• Ability to exercise sound judgment when handling technical and operational challenges.

• Strong stakeholder management and collaboration skills.

• Ability to lead discussions, resolve conflicts, and drive projects toward successful completion.

Essential Skills

• Manufacturing Lifecycle Management (LCM) Engineering

• Manufacturing Engineering Support

• Medical Device Quality Systems

• Orthopedic Manufacturing and Metal Implants

• FDA, MDD, MDR, and GMP Compliance

• Product Lifecycle Management (PLM) – Windchill

• Change Control and Technical Documentation

• IQ/OQ/PQ and Process Validation

• External Manufacturing and Supplier Management

• Cross-Functional Project Leadership

Experience Requirements

• Overall experience: 6–8 years.

• Medical device quality systems experience: Minimum 5 years.

• Project leadership: Proven experience leading technical projects and cross-functional teams.

• Industry preference: Medical devices, particularly orthopedic implants and metal implant manufacturing.