Director of Research Development

Job Description

An exciting opportunity with a globally renowned leader in imaging technology in healthcare, pioneering innovative solutions that enhance people's lives every day

• 20+ years of experience in medical or technical device development with 15+ years in the medical domain
• 15+ years managing projects or as an R&D Core Team Member
• 7+ years building and managing R&D engineering teams

• Developing and launching medical devices from concept to launch
• Driving innovation, design and cost
• Working with hospitals and healthcare professionals to identify new opportunities and develop business portfolio expansion for India
• Working with global leaders to develop business case for India R&D expansion
• Setting up R&D centers for global Product development
• Setting up lab capabilities in electromechanical systems testing, design verification and real time testing
• Automation of test methods and overall testing process
• Budget management, forecasting and monitoring
• Highly developed specialist knowledge in clinical engineering underpinned by theory and experience.
• It is essential that the candidate has extensive working knowledge and application of FDA requirements, including 820CFR, ISO-13485, ISO14971, ISO-10993, IEC60601, IEC62304, IEC62366 as well as other standards as they relate to the design, development and manufacture of medical devices.
• Capable of ensuring high quality work product, proactive solution generation, high productivity, and continuous improvement.
• Expertise in FDA Design Controls and development of medical devices.
• Proficient with the creation and critical review of engineering drawing and specification documentation.
• Proficient in requirements management
• Experience managing external development partners.
• Capable of building strong relationships with internal customers, maintains awareness of their needs, responds promptly to all requests, and appropriately manages expectations.
• Must be capable of effectively managing internal and external resources in light of varying priorities and responsibilities without over-committing.
• Experience of managing a multidisciplinary team, including biomedical engineers and clinical technologists
• Extensive knowledge of the full range of advanced medical technology in an acute NHS Trust Practical experience of reporting and presenting to executive level meetings and senior management
• A firm foundation of experience in the new product development of medical devices and the medical device industry, and a thorough understanding and effective application of project management leadership skills and techniques.
• Management of people including staff recruitment, discipline, and development
• Management and delivery of program of medical device replacements.
• Demonstrated interest in research, innovation, and publication.
• Managing capital and revenue budgets in compliance with NHS Finance and SFI's
• Medical device safety through and MDSO role
• Extensive knowledge and experience of external regulations as relevant to medical devices
• Excellent team management skills and ability to develop clear and concise communication to a wide range of stakeholders (asset and deliverable teams, functional leadership, Governance Boards, collaborators, and development partners) is required.
• Ability to guide teams to align operational project plans with approved asset strategy, proactively identify potential problems, and lead risk management assessments.

• A degree or higher qualification in Engineering from a recognized university.
• Masters in Engineering or Business Management is required.