Director of Research Development

Purpose of the Role:

The India R&D & BOT lead is responsible for the establishment of India R&D capabilities in the India center for new product development. The individual will head electrical, mechanical, systems, embedded and digital engineering functions with direct reporting from the function heads. This is a critical role in establishing capabilities and owning the end-to-end delivery for the R&D and BOT scope of work (with the vendor initially, to be transition to the incubator once BOT ends) post the transition.

In this highly collaborative role, the Director will collaborate across Business Units, R&D, and applicable functional groups, to identify and implement areas of improvement and optimization to our systems, processes, procedures, and tools.

The ideal candidate shall be a hands-on technical leader with demonstrated experience in:

• Developing and launching medical devices from concept to launch
• Driving innovation, design, cost and business 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

The candidate should be a device subject matter expert (SME) in Design Controls and product development process for systems, Device, Hardware and Software (Experience overseeing external SW/HW development is highly preferable).

The Director must be expert in Design Controls both in owning and executing a project, and the processes and deliverables associated with the development of medical devices and the systems cradle to grave. (User Requirements to Field data analysis)

This Director shall also work with other R&D leaders, and functional leaders (e.g., Regulatory and Quality), to implement changes when new regulatory guidelines, or applicable standards, are issued that affect product development.

Key Responsibilities:

India R&D setup, growth and vision:

Setup lab capabilities in electromechanical systems testing, design verification and real time testing

Design and implement automation of test methods and overall testing process

Work with India R&D head to own the budget forecasting, management and monitoring

Deliver and administer effective and efficient continuous improvement tools

Direct the recruitment, training, mentoring and upskilling of the entire function

New product development (incubator scope):

Head the overall India R&D organization to own and be accountable for the delivery, execution and performance of overall scope of R&D operations from India for New Product development in accordance with regulatory and medical requirements

Partner with Development centers (DCs) across the globe to collaborate and execute R&D projects across India capabilities

Establish and foster relationships with internal and external partners, establish trust and support cross-functional peers as appropriate

Lead design and development efforts over the continuum of product development; coordinate, deliver, plan & communicate R&D deliverables on the program and maintain collaborative relationships with the DC heads, global and local PMOs and other teams/stakeholders involved

Partner with development center heads/project leads, PMO/VMO lead and global PMOs to manage the overall coordination and management (organization, planning, execution, monitoring, and control) of NPD R&D projects

Work closely with Functional leads (electrical, embedded, systems, digital, mechanical) and onsite and offshore PMO teams to develop team strategy, ensure aligned execution plans, and drive the execution of the strategy

Ensure the decisions and actions of the team, and themself, is consistent with Olympus’s Quality, Business, Cost, and Delivery expectations

Own and develop new tools to support and improve efficiency in the development process

Work with functional leads develop templates to support a consistent approach internally and with external design partners

Actively monitor technical and project risks and implement contingency plans where appropriate

Work with functional leads to mentor team members as necessary, as well as champion any training and/or tools necessary to create a consistent approach to all programs and efforts (assists in building a high performing culture)

Manage and lead the R&D team (own hiring strategy, upskilling, training, attrition)

BOT and R&D scope of work transition:

Work closely with functional leads and the vendor partner to oversee, own and manage outsourced R&D scope of work in the BOT model

Provide technical expertise, strategic insights, and course correction interventions for the vendor

Work closely with the PMO team to liaison technical expertise between DCs and vendor

In collaboration with the PMO, identify key risks/issues and envision mitigation strategies for the same

Lay foundations to own and deliver the vendor scope of work from the India incubator R&D function once BOT scope of vendor projects is transitioned to the incubator R&D function

Work closely with vendor program leads to develop transition plans for insourcing the BOT scope of work into the incubator R&D function

Lead and own the BOT transition planning from the scope of people and processes

Regulatory & Compliance:

Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications

Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards

Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations

Risk Management & Problem-Solving:

1. Identify potential technical risks and implement mitigation strategies
2. Provide technical guidance in solving engineering challenges during the product development lifecycle

Person Specification:

Education

A degree or higher qualification in engineering from a recognized university.

Masters in engineering or business management is required.

Experience

• 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

Skills

• 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.