Overview
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.
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 tests development for medical devices
* Manage resources needs, costs, schedule, 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 product 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.
Qualifications
* 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 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 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 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 or call in confidence 0860204322
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