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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

R&D Director/CTO Start Up Medical Device


Reference:JCAO220603 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client an early stage up medical device company are currently seeking a Director of R&D/CTO to join their team. As a key early employee in a valuable leadership position, you will be joining a senior leadership group steering the company’s growth, value and culture. This is a full time, permanent role based in Galway, Ireland with a hybrid work-from-home opportunity and flexible working hours. Limited travel will be required depending on the project phase. The R&D Director will report directly to the CEO. A highly competitive remuneration package is available commensurate with experience and incorporating share options to enable the successful candidate to share in the company’s overall value as we grow.


Role/Responsibilities

  • Accountable for shaping and delivering the product development programme for initial class II device
  • Establish R&D programme objectives, timelines, milestones and budget with the leadership team.
  • Identify and mitigate technological risks throughout the design process. Promote problem-solving techniques within the team.
  • Developing a pipeline portfolio of diverse health products, working from basic clinical need through opportunity assessment and device concept to prototype.
  • Effectively represent company while interacting with Clinicians, women users, to distil their needs into product requirements and concepts. Engage scientific advisors to screen product ideas.
  • Apply an understanding of anatomy and physiology with engineering knowledge in materialsand processes to come up with working designs.
  • Lead the development and management of the company’s intellectual property portfolio.
  • Shape the structure of the R&D function; recruiting, leading, managing and developing a team of highly talented engineers.
  • Provide leadership in technical innovation across the department championing a culture of innovation.
  • Manage any external contractors to deliver on time, cost and performance targets.
  • Work alongside the QARA Manager in the delivery and implementation of an appropriate QMS, ensuring full participation/policy adherence within the R&D function.
  • Partner with internal functions including Manufacturing, Supply Chain, Quality Assurance,Clinical and Regulatory to drive the timely completion of market clearance application(PMA/510k) to the FDA and EMEA.
  • Oversee and manage technology transfer to the manufacturing process, interfacing effectively with subcontract manufacturing and other suppliers to deliver on agreed product specifications
  • Work with senior team members to develop further grant applications for product development opportunities.

Skills/Experience
  • Degree level 8 in Engineering or related discipline (Life science, Bio-medical/ Science) with 8 –15 years’ relevant experience within medical device environment.
  • Proven track record in medical device product development including innovation and project/program management, design theory, risk analysis, problem-solving skills and technical leadership.
  • Prior experience of bringing a medical device through the full development cycle including clinical studies/regulatory approval.
  • Knowledge of regulatory standards and design control systems.
  • Experience in early research aspects of product development desirable.
  • Demonstrated people management skills including recruiting, on-boarding, training and development.
  • Intellectual property development and strategy experience is an advantage.
  • Strong communication and presentation skills to lead or facilitate effective discussions and relay technical and/or project information to key stakeholders.
  • Dynamic team player and leader that can work effectively and proactively collaborate on cross-functional teams.
  • Experience in working with KOLs to identify unmet therapy needs.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322