Telephone: 086 8395533
Research and Development Programme Manager – Medical Device
Our client, a medical device company in Waterford are currently looking to recruit a Research and Development Programme Manager for their site.
- A high calibre, senior level R&D engineer/executive that has successfully managed a team, design process and NPD project to develop a medical device product under the ISO13485 standard, from concept stage right through to product launch and post market follow up.
- The ability to converse with confidence/gravitas when communicating with clinicians, Kols and customers to promote the company and effectively capture "voice of the customer" inputs is highly desirable.
- While not a requisite, having experience developing connected healthcare and IoT enabled devices to support the company’s strategy in this direction is a huge advantage.
- This is a hands on role to manage and coordinate all activities relating to the NPD Programme at the company.
- The Programme manager will lead, support and work with the team to develop orthopaedic devices using the company’s proprietary materials and technology that will deliver clear clinical, functional and economic benefits to patients, practitioners and healthcare organisations worldwide.
- The Programme manager will motivate and coordinate the team to achieve their respective project objectives within specified time lines and:
- Work closely with the R&D Director to implement the company’s strategy and achieve its business goals.
- Ensure that technologies, products and devices are developed to comply with relevant regulatory standards and CE certification requirements.
- Coordinate transfer of R&D projects to pilot & series manufacturing and be familiar with all related quality and regulatory protocols necessary.
- Support marketing to ensure timely product launches and manage the company’s training programme to train clinicians and customers on how to effectively use company products so as to secure and accelerate product adoption in the market.
- Contribute as required to the development of company strategy and future business plans.
- Min degree in any of the following disciplines: Mechanical or Polymer engineering, Industrial design, Chemistry, Biomechanics or Materials Science.
Minimum experience and requirements:
- The candidate must have a minimum 3 years working in the medical device sector, have at least 2 years “Hands on” experience supervising a team in a R & D / product development environment, and have a proven programme/project management track record.
- Ideally, the candidate will have worked under an ISO or FDA regulatory system, have experience of product verification and validation procedures and techniques and are capable of managing NPD projects from conception to product commercialisation.
- Familiarity with design and development procedures and experience of building or contributing to a "design history file" during product development is a serious advantage.
- Experience of patents and IP, including preparation of patent specifications, is a distinct advantage, as is set-up and V&V experience of manufacturing systems and the preparation of technical agreements and protocols.
- Experience of tool design and injection moulding is an advantage as is experience with CAD drawing packages.
- In addition to being creative, resourceful and an Innovator, the successful candidate will have strong leadership capabilities; be a self-starter with a proven project management track record.
- The successful candidate will be highly self-motivated, a decision maker, entrepreneurial in spirit, and performance driven.
- Ideally the candidate will have experience of supervising small teams and therefore be an excellent communicator, influencer and motivator with a proven ability to build, manage and maintain relationships at all levels.
- The ability to "Think outside the box" means the candidate can work on their own initiative while their disciplined approach to problem solving and task completion ensures timely delivery of project milestones.
- A clean driving license with own transport is required.
General Duties & Responsibilities
- Reports to the R&D Director
- Supervision of R&D department, staff and facilities
- Develop NPD project plans with stakeholders
- Update, maintain and monitor project plans in line with company objectives.
- Works to achieve goals and objectives as defined in R&D project plans
- Carry out D&D activities, procedures, FMEcA, Risk analysis etc.
- Material development, testing and characterisation
- Product/device development at all phases (idea generation through to commercialisation)
- Control and preservation of proprietary and third party intellectual property.
- Ensure that all intellectual property generated at the company is captured, stored, and protected.
- Liaison with Clinicians, Customers, Universities, Institutes, suppliers and commercial organisations when required.
- Market research - VOC: Liaise with Clinicians and market stakeholders to generate product user requirements for NPD projects.
- Coordinate clinical studies and trials
- Conduct training workshops with clinicians and customers.
- Manage and maintain accurately all documentation relating to the R&D Tax credit scheme. Generate detailed status reports and documentation to support submissions for R&D tax credits claims.
- Support marketing
- Prepare ongoing progress reports on a monthly basis or as requested
- Liaise with appointed consultant(s) and person(s) with overall responsibility for quality and regulatory affairs at the company.
- Monitor regulatory issues relating to medical devices under development.
- Prepare patent drafts with validated information and specifications
- Responsible for implementing systems and procedures to satisfy the requirements associated with R&D grant scheme applications and subsequent claims.
- Ensure that NPD development is compliant with the company’s regulatory and quality systems, procedures, documentation and CE marking criteria.
- Generation and control of documentation for design history and technical files etc.
- Prepare and submit submissions for Research and business development funding
- Is willing to travel if required for the company.
For further information on this Research and Development Programme Manager role in Waterford please contact Bimi Felix on 086 8395533 / email@example.com
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