Director, Medical Devices
2001-30000
Other
What are you going to do
Essential skills and knowledge
- Manage and provide leadership to Medical Device Product Development and engineering teams.
- Collaborate with cross-functional teams involved in Medical Device Development, including Quality, Supply Chain, Manufacturing, and Marketing.
- Mitigate and manage Medical Device Program risks by establishing and executing contingency plans.
- Lead and implement customer-centric medical device design programs.
- Work closely with Key Opinion Leaders (KOLs) and participate in clinical experience programs.
- Hire and lead the medical devices engineering team.
- Provide capital and human resource recommendations to support the execution of the Company's Product Development plan.
- Act as a Subject Matter Expert, ensuring compliant and robust medical device development and design history files.
- Lead the transition from development to commercial launch for medical devices.
- Facilitate the closure of the development gap between drug and device.
- Work collaboratively with Product Marketing & Business Development personnel to define the scope and requirements of potential development projects and product requirements throughout the life cycle of medical device products.
- Oversee Electrical Safety and EMC testing of Medical Devices as applicable.
- Lead the establishment and management of the engineering and design review board for medical device changes.
- Review proposed design changes and manufacturing process changes for Medical Devices.
- Manage the creation and maintenance of design history files and related risk management files.
- Approve Corrective and Preventive Actions (CAPAs) and investigations.
Essential skills and knowledge
- Bachelor's degree in Electrical/Mechanical Engineering.
- 10 or more years of experience in the Medical Device industry.
- Experience with software-driven medical devices.
- At least 10 years' experience in the development of software-driven medical devices for the EU or US markets.
- Proven experience managing cross-functional teams.
JOB SUMMARY