Medical - Principal Manufacturing Engineer - Arlington, MA

PageGroup - Arlington, VA

Full-time - Principal

Arlington, VA

Administrative and Support Services

About the position

The Principal Manufacturing Engineer will play a pivotal role in leading technical efforts on manufacturing projects, specifically within the medical device sector. This position is crucial for ensuring that innovative and cost-effective solutions are developed for medical device projects, particularly those aimed at transforming cancer surgery with a focus on breast cancer. The successful candidate will be working in a mission-driven environment, where the company is transitioning from clinical development to commercial launch, addressing significant challenges in cancer care. In this role, the Principal Manufacturing Engineer will oversee multiple contract manufacturers responsible for producing medical device components. This includes collaborating closely with suppliers and contract manufacturers to define and document manufacturing processes, while also identifying and mitigating associated risks. The engineer will conduct validation and qualification activities, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for optical devices, ensuring that all processes adhere to stringent medical device manufacturing regulations, including 21 CFR 820. The position requires applying design control principles and developing comprehensive manufacturing protocols. The Principal Manufacturing Engineer will partner with cross-functional teams to identify and implement process improvements, review and approve component and equipment specifications, and update site procedures as necessary. Additionally, the engineer will be responsible for designing and procuring tools and fixtures that meet the specific needs of manufacturing operations.

Responsibilities

• Oversee multiple contract manufacturers for medical device components.
• Collaborate with suppliers and contract manufacturers to define and document manufacturing processes, including risks.
• Conduct validation and qualification activities (e.g., IQ/OQ/PQ) for optical devices.
• Ensure adherence to medical device manufacturing regulations (e.g., 21 CFR 820).
• Apply design control principles (e.g., 21 CFR 820.30) and develop manufacturing protocols.
• Partner with cross-functional teams to identify and implement process improvements.
• Review and approve component and equipment specifications, and update site procedures as needed.
• Design and procure tools and fixtures to meet manufacturing needs.

Requirements

• BS or MS in Mechanical or Manufacturing Engineering.
• 15+ years of experience in the medical device or pharmaceutical industry, in a team-based setting.
• In-depth knowledge of medical device manufacturing regulations (21 CFR 820, cGMP, ISO-13485, etc.).
• Experience with low-volume optical-mechanical devices and sterile disposables.
• Experience with Class III Medical Devices.
• Background in endoscope, imaging, or machine vision.
• Knowledge of plastics, injection molding, and assembly of small parts.
• Process/Operations excellence training or certification (Six Sigma, Lean, Green or Black Belt).
• Basic CAD skills (SolidWorks or OnShape), PDM experience.
• Ability to prioritize tasks and resources effectively.

Benefits

• Competitive compensation package with opportunities for financial growth.
• Extensive health and wellness benefits.
• Career development programs and mentorship.
• Creative, collaborative work environment.
• Flexible work arrangements for work-life balance.
• Access to cutting-edge technologies and continuous learning.
• Involvement in high-impact, innovative projects.
• Opportunities for industry leadership and global networking.