Job Title: Senior Manufacturing Engineer – Medical Device (Implants)
Location: Mid-Atlantic / Northeast, United States (Hybrid)
Duration: 1 Year contract
Job Summary:
We are seeking an experienced Senior Manufacturing Engineer to support a leading medical device manufacturing organization. This role focuses on implantable medical devices, with strong involvement in metal machining processes and supplier change management. The ideal candidate will work cross-functionally with internal teams and external suppliers to ensure successful execution of manufacturing and supplier initiatives.
Key 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/manufacturing processes related to implantable devices
- Coordinate with external suppliers and contract manufacturers for change implementation
- Lead or support process improvement and continuous improvement initiatives
- Ensure compliance with medical device regulations and quality standards (FDA, ISO)
- Provide technical guidance and drive project execution across cross-functional teams
- Maintain documentation related to change control, validation, and risk assessment
Required Qualifications:
- Bachelor’s degree in Mechanical, Manufacturing, or related Engineering field
- 5+ years of experience in medical device manufacturing, specifically implantable devices
- Strong experience in metal machining/manufacturing processes
- Hands-on experience with supplier change management / supplier quality engineering
- Knowledge of FDA regulations and ISO standards (e.g., ISO 13485)
- Excellent communication and stakeholder management skills
Preferred Qualifications:
- Experience with orthopedic, spine, trauma, or surgical implants
- Background with leading companies in implantable medical devices
- Strong project management or leadership experience
- Familiarity with validation processes (IQ/OQ/PQ) and risk management
Key Skills:
- Manufacturing Engineering
- Supplier Change Management
- Metal Machining
- GMP / Regulatory Compliance
- Cross-functional Collaboration
- Process Improvement