Introduction

We are hiring for a Director of Medical devices, to join a leading pharmaceutical company specializing in nuclear medicine. They have expertise in both diagnostic and therapeutic radiopharmaceuticals, as well as innovative medical devices. They are committed to quality, patient care, and dedicated to advancing healthcare through cutting-edge technologies. As the Director of Medical Devices, you will play a pivotal role in shaping the future of their medical device portfolio.

What are you going to do

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.

What we offer

What We Offer

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About Us

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