Food Service Worker assisting with food preparation and maintaining kitchen safety standards in the William Penn School District. Ensuring cleanliness and organization in the kitchen environment.
MS
Hybrid Associate Director, Drug/Device Combination Products Tech Transfer
Posted last month
About the role
- Associate Director in medical device tech transfer overseeing global commercialization and project management. Collaborating cross-functionally to ensure compliance and drive product robustness.
Responsibilities
- Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally
- Develop and execute strategic plans for technology transfer
- Provide Voice of Manufacturing input to early development teams
- Author and complete regulatory filing sections, and support response to questions and pre-approval inspections
- Secure early sponsorship and stakeholder alignment for projects and initiatives
- Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance
Requirements
- Technical BS degree or higher
- BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar preferred
- 8+ years of experience in medical device or combination product engineering
- Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging
- Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
- Exceptional project management skills and principled verbal and written communication abilities
- Experience collaborating with combination product development teams and working groups
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Job title
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