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 ****** or call in confidence at 0860204322.
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