Senior R&D Manager/Director

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

• 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.