Senior Manufacturing Engineer

Job Title : Senior Manufacturing Engineer / Lead

Location : PA, United States (Hybrid)

Employment Type : Contract (W2 / 1099)

Rate : $50-60/hr ( DOE )

Duration : 12+ months

About the Role

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.

Responsibilities

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

Required Qualifications

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

Preferred Qualifications

Experience leading manufacturing projects or initiatives

Background in process improvement and continuous improvement methodologies

Strong communication and stakeholder management skills