Key skills
LeadershipProject ManagementCommunication
About this role
Role Overview
- Provide strategic program leadership in developing and transferring medical devices
- Collaborate with a team to support global and site-specific projects
- Ensure compliance with regulatory standards and quality management systems
- Drive product robustness for sustained launch
- Author and complete regulatory filing sections
Requirements
- Technical BS degree or higher
- 8+ years of experience in medical device or combination product engineering
- Demonstrated technical leadership in Technology Transfer and Design Transfer
- Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
- Exceptional project management skills
- Verbal and written communication abilities
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