Medical Manufacturing Engineer
1 day ago
As a Principal Manufacturing Engineer, you will oversee multiple contract manufacturers for medical device components, collaborating with suppliers and contract manufacturers to define and document manufacturing processes, including risks. You will conduct validation and qualification activities (e.g., IQ/OQ/PQ) for optical devices, ensuring adherence to medical device manufacturing regulations (e.g., 21 CFR 820).
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 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.
- 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.
- 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.
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