Medical Device Product Development Manager

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Job Description

Position Summary:

 

Medical Device Product Development Manager will be responsible for the successful completion of Medical Device development through to commercialization and continuous life cycle management.

 

Key Activities:

 

  • Lead Medical Device Product Development Programs and Life-cycle management of existing devices.
  • Communicate with key stakeholders on a regular basis (as required) and provide updates to Management in a timely manner.
  • Manage and provide leadership to Medical Device Product Development teamand cross-functional teams involved in Medical Device Development .
  • Manage Medical Device Program risks ensuring mitigation and contingency plans are established and executed.
  • Provide capital and human resource recommendations with supporting justification to support execution of the Company’s Product Development plan.
  • Manage Service Program for Medical Devices.
  • Act as Subject Matter Expert ensuring compliant and robust medical device development & design history files.
  • Lead transition from development to commercial launch for medical devices.
  • Leadership role in facilitating closure of 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 establishment and management of engineering and design review board for medical device changes.
  • Lead and implement customer centric medical device design programs, inclusive of close involvement with KOL’s and clinical experience programs .
  • Review proposed design changes to Medical Devices.
  • Review proposed manufacturing process changes for Medical Devices.
  • Manage the creation and maintenance of design history files as well as related risk management files
  • Management and approval of CAPA’s, investigations.
  • Oversight of the manufacture and supply of medical devices during the development phase.
  • Perform other duties as required by Director PET Cardiology Products.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

Required Qualification:

 

  • Bachelor degree of Electrical/mechanical Engineering.
  • 5 Years Medical Device Experience.
  • Experience with software driven medical device.
  • 5 years’ experience in the development of software driven medical devices for the EU and US markets.
  • Experience managing cross functional teams.
  • Prior knowledge and experience  of the following standards:
  • IEC 62304 (software management for medical device (NTH)
  • ISO  13485 Quality System management experience
  • 21 CFR - Parts 820 Quality System Regulation
  • ISO 14971 Risk management
  • IEC 60601-1 and 60601-1-2 Experience
  • CMDCAS
 
 
 
 
 
 
 
 
 
 

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Details

Posted: Sep 15, 2020

Type: Full Time

Category: Product Development