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Details
Senior R&D Manager/Director
Reference: | JCAO1610 | Location: |
Dublin |
Qualification: | Degree | Experience: | 10+ Years |
Job Type: | Permanent | Salary: | Not Disclosed |
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
- Lead and direct the system and hardware development activities for cutting edge
- Provide technical leadership for developments through concept, prototype, design
- Manage resources needs, costs, schedule, key milestones, scope and development
- Lead DHF (Design History File) deliverables with key stakeholders, and work within
- Ensure compliance with applicable standards and regulations, including FDA
- Communicate with external vendors to ensure design intent is translated into
- Evaluate trade-off decisions and present actionable information to leadership
- Provide leadership with the planning and execution of multiple projects in parallel
- Ensure effective communication and collaboration within the R&D team, and foster
- Contribute to the company’s growing intellectual property portfolio through
- Exhibit a great attitude as a team player who excels in a demanding start-up
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
- 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
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