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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior R&D Manager/Director


Reference:JCAO1610 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: R and D Director, R and D Manager, Research and Development

Our client a high potential start up currently seek an experienced Senior R&D Manager/Director for managing design, development and verification of a next generation devices. Reporting to the CTO The R&D Manager will have extensive experience in systems engineering, mechanical and electronic hardware engineering. The Senior R&D Manager will have a strong background in developing medical devices in compliance with applicable FDA and ISO standards and regulations CFR as well as MDD provides the foundation for this role.



Role/Responsibilities:

  • Manage our multi-disciplinary and multi-site R&D hardware team to develop next
generation products.
  • Lead and direct the system and hardware development activities for cutting edge
devices.
  • Provide technical leadership for developments through concept, prototype, design
and tests development for medical devices
  • Manage resources needs, costs, schedule, key milestones, scope and development
goals within your team according to company milestones.
  • Lead DHF (Design History File) deliverables with key stakeholders, and work within
our design control process, meeting Quality Management System requirements.
  • Ensure compliance with applicable standards and regulations, including FDA
requirements, notified bodies, and ISO standards.
  • Communicate with external vendors to ensure design intent is translated into
product effectively.
  • Evaluate trade-off decisions and present actionable information to leadership
stakeholders in exchange with Senior Program Management.
  • Provide leadership with the planning and execution of multiple projects in parallel
within the R&D department.
  • Ensure effective communication and collaboration within the R&D team, and foster
a culture of innovation and continuous improvement
  • Contribute to the company’s growing intellectual property portfolio through
innovation and invention.
  • Exhibit a great attitude as a team player who excels in a demanding start-up
environment.



Skills/Experience
  • 10+ years of experience in R&D leadership in the Medical Device Industry.
  • Demonstrated track record in leading and managing cross-functional multi-site development activities to execute product development from early concept through commercialization.
  • Strong technical expertise in systems engineering and expertise in complex electronic, mechatronic and mechanical components, preferably with imaging systems.
  • In-depth knowledge of applicable standards and regulations related to medical devices, including FDA requirements, notified bodies, and ISO standards.
  • Strong interpersonal and leadership skills, managing cross-functional and multi-disciplinary teams across multiple sites.
  • Experience in working within Quality systems for Medical device development.
  • Experience in hardware and systems development of complex medical devices.
  • Experience in ultrasound a significant advantage.
  • Experience with design for manufacturing (DFM) and design for reliability (DFR) principles.
  • Proven track record of leading successful product development programs, from concept through commercialization.
  • Master’s degree in Mechanical/Electronic Engineering or related fields from anaccredited college or university is preferred.
  • Hands-on mindset and creativity for problem-solving within multi-disciplinary teams.
  • Extensive experience in project management, preferably including agile methodologies.
  • Track record of efficient decision making, and team leadership at the face of complex technical challenges.
  • Use of metrics as indicators of potential roadblocks, risks, and issues which could block successful achievement of the program goals.
  • Open-minded personality and excellent communication skills in English are
Essential
  • Strong work ethics with a team-oriented mindset
  • Ability to travel up to 25% annually within Europe as well as internationally.


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