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. #J-18808-Ljbffr