Senior Manufacturing Engineer​/Lead

Job Title :
Senior Manufacturing Engineer / Lead – Medical Device (Orthopedic Implants)

Location : PA, United States (Hybrid)

Employment Type :
Contract (W2 / 1099)

Duration : 12+ months

This role supports manufacturing and supplier initiatives for implantable orthopedic medical devices. The Senior Manufacturing Engineer will focus on metal machining processes, supplier change management, and cross-functional project execution in a regulated environment.

• Review and assess supplier change requests for manufacturing processes and components
• Collaborate with R&D, Quality, Regulatory, and Supply Chain teams to evaluate impact and ensure compliance
• Support metal machining and manufacturing processes for implantable devices
• Coordinate with external suppliers and contract manufacturers for change implementation
• Lead process improvement and continuous improvement initiatives
• Ensure compliance with FDA and ISO quality standards
• Provide technical leadership and drive cross-functional project execution
• Maintain documentation for change control, validation, and risk assessments

• Strong experience in medical device manufacturing, specifically orthopedic implants
• Experience with metal machining processes
• Experience with supplier change management and change control processes
• Strong project management and cross-functional collaboration skills
• Knowledge of FDA regulations and ISO standards
• Experience working with suppliers and contract manufacturers

• Experience leading manufacturing projects or initiatives
• Background in process improvement and continuous improvement methodologies
• Strong communication and stakeholder management skills

The hourly rate for this position is $50-60 per hour ( DOE )

This is a contract position and does not include employer-provided benefits.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable laws

Applicants must be authorized to work in the United States