Senior R&D Manager/Director

3 weeks ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time

Our client, a high potential start-up, is currently seeking an experienced Senior R&D Manager/Director for managing the design, development, and verification of 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, as well as MDD, which 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 test development for medical devices.
  • Manage resource needs, costs, schedules, 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 products 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 is 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 an accredited 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 in 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.
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 at james.cassidy@lifescience.ie or call in confidence at 0860204322.
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