Director Quality Management at Sunfire responsible for quality chain optimization and team leadership. Focused on improving product development and compliance across international locations.
MS
Hybrid Associate Director, Drug/Device Combination Products Tech Transfer
Posted 3 days ago
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
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