Orthopedic LCM Engineer – External Mfg & Windchill

SFE; West Chester (Chester County); On-site; USD 90,000 - 100,000; Full time

Job summary

SFE is seeking an LCM Engineer in West Chester, PA to lead lifecycle management projects for orthopaedic metal-implant products. You will work with external manufacturing partners, oversee technical aspects, and ensure compliance with quality and regulatory standards.

You will coordinate cross-functional teams, review technical documentation, and drive qualification and validation activities across processes and equipment.

Qualifications

• Degree level or equivalent in manufacturing engineering in orthopedics (metal implants) leading lifecycle management projects with external partners.
• Minimum 5 years in medical device quality systems in varied operational tasks.
• Knowledge of FDA, MDD and MDR GMP requirements.
• Experience leading cross-functional teams.
• Effective communication with external partners and internal functions; capable of project and technical leadership.

Responsibilities

• Lead and execute Life Cycle Management projects for finished goods with external manufacturers, on time and within scope.
• Provide technical oversight and leadership for external partners; assess scope, business case, feasibility and implement per quality/regulatory requirements.
• Utilize Windchill and other PLM tools to manage documentation, change controls, and project activities.
• Collaborate with Quality, R&D, Regulatory Affairs, Source, Plan, and Operations to meet supply chain priorities and project deliverables.
• Facilitate collaboration with internal and external stakeholders, proactively resolve issues and manage risks to customer service.
• Review and approve technical docs, including drawings, process docs, IQ/OQ/PQ protocols, qualification and validation reports.
• Manage asset decommissioning/disposal with external partners and coordinate internal dispositions.

Skills

Manufacturing engineering

External partner liaison

QA systems knowledge

Education

Engineering degree

Tools

Windchill

IQ/OQ/PQ

PLM

Job description

SFE is seeking an LCM Engineer in West Chester, PA to lead lifecycle management projects for orthopaedic metal-implant products. You will work with external manufacturing partners, oversee technical aspects, and ensure compliance with quality and regulatory standards.

You will coordinate cross-functional teams, review technical documentation, and drive qualification and validation activities across processes and equipment.