Medical Devices JobsR&D Manager – Startup

  • GY50682
  • Permanent
  • Galway

Collins McNicholas

Key Accountabilities:

  • Research, identify, ideate, invent, conceptualize, design and develop new product development and create the funnel for new product development opportunities
  • Analyse, align, absorb and accommodate customer needs vs field issues on product development and develop cost-effective solutions in the product development cycle
  • Align with organizational goals and work with global teams in the life-cycle process of New product Development – involving research, design, develop, build prototypes and transfer to manufacturing
  • Incorporate the concepts of ‘Quality by Design’ and ‘Robust Design’ concepts into new product development
  • Involve in product quality investigations, provide support to resolutions and work with cross-functional teams in product quality improvement ideas and opportunities
  • Contribute and demonstrate the application of the concepts of Design for Six Sigma and Lean in product development cycle
  • Identify, develop and nurture vendors in the product development process
  • Pilot and lead effective design control processes, tools and effective documentations
  • Interact and implement all the quality system and regulatory needs of both in-house and external regulatory processes. Accountable for the QMS and regulatory system process at the site.
  • Learn, listen and lead inclusive traits to work collaboratively in a multi-cultural and multi-locational environment
  • Actively engage with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care
  • Solve issues through information exchange, influence and active persuasion without the direct exercise of command to gain the cooperation of other parties on program execution plans.
  • Contribute, mentor, lead and review the technical work of the team in the local site. to develop, nurture and maintain a high performing technical team at the site
  • Lead, innovate, develop and sustain cost-effective solutions involved in product and people development process
  • Ensure deliverables are met on-time plans and plan, budget and procure appropriate process.

Eligibility criteria

  • 15 + years of proven, progressive technological expertise with deep skill and knowledge in medical device development with broader knowledge on manufacturing processes.
  • Demonstrated expertise in one or more of the following (not limited to) new/innovative product development is required

           -Delivery System development expertise – Coronary, peripheral, structural heart, Chronic total occlusion specific products

           -Specialty Balloon and delivery Systems – Micro -Catheter, Guide Linear, Scoring and cutting Balloons

           -In-depth product expertise in any one of the implantable cardiology  products like AAA, TAVI, TVMR, Pulmonary Valve, Occluders

           -Manufacturing expertise in Shape Memory (NiTi) based implantable cardiovascular products

  • Doctoral / Masters Degree/Honors Degree in Engineering disciplines  –  Mechanical / Bio-Medical / Polymer / Structural / Bio-Mechanics
  • Built and lead a high performing technology team in a multi-national environment
  • Patents and Publications

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