Our client a Company whose main business focuses on medical applications for hospital and outpatient use. Devices are sold globally through a network of distributors.
Both the underlying technology and the products for medical applications are supported by company-owned, strong IP. Product manufacturing, currently all outsourced to third party contractors, is well established with good regulatory approval.
Our client has a strategy of progressively bringing key competencies in house, thereby building greater depth and long term succession into the technical team.
They’re seeking to appoint a Product R&D Engineer with a strong and relevant scientific background, relevant programming experience, and some experience of working in industry, preferably in medical devices.
This is a crucial role for the successful expansion of the company into a substantial business over the next several years so the job holder will be expected to grow with the Company and to increasingly influence and make strategic input into shaping the business as it goes forward.
This is a significant opportunity for the right candidate to join an ambitious and well-resourced company at a relatively early stage of its development in a practical hands-on role, and then progress further within the R&D function.
The Role
The Product R&D Engineer will work with the Head Of Product R&D and external consultants to design low cost, “fit for purpose” medical devices, taking into account the overall design of the product (both current and future), the regulatory environment, and the ability to scale up production.
The job holder must demonstrate a broad knowledge of physics, electronics, electrical engineering, software development and product design in the context of the medical devices industry.
Main Initial Responsibilities
- Help design PCBs and software for next generation devices, including accessories, and undertake testing of hardware and software components
- Support the verification testing of existing products, new components for product enhancements, and complete any relevant manufacturing documentation
- Implement any design changes necessary for the verification of new materials
- Play a key role in research into new materials and capabilities for future product developments
- Diagnose product complaints received, identifying the root causes of any problems. Systematically capture all analysis and resultant actions in CAPA system.
- Write and manage all inputs and analyses required for the Company’s technical files, working closely with the Company’s regulatory consultant.
- Work with Manufacturing to identify and evaluate suppliers for new product components.
- Work with Manufacturing on the technical aspects of manufacturing scale up, regularly visiting manufacturing facility in Wales.
Dimensions
Current annual R&D spend (inc Clinical and Regulatory); £1m.
Current annual sales; c£4m, expected to grow rapidly
Person Profile
Experience, Skills and Characteristics
- Broad technical experience spanning physics, electronics (PCB design), electrical engineering and product design
- Programming experience essential, particularly of embedded ‘C’, but also some knowledge of ‘Python’, Visual Basic and scripting languages
- Minimum of 2 years’ relevant industrial experience, preferably in medical devices
- Working knowledge of all relevant regulations and standards that pertain to medical devices preferable
- Effective team worker with good collaboration and influencing skills for working with industrial design experts, biologists and business partners
- Proactive with good trouble shooting skills
- Good communication skills, both written and verbal
- Commercially aware, and experienced in working with rapidly growing entrepreneurial stage companies
- Able to combine specific knowledge and scientific rigour with a broader understanding of the overall product and its current and future commercial context, and the regulatory environment
- Comfortable with a rapidly changing environment and able to cope with ambiguity and shifting priorities
- Able to contribute effectively as a member of a small but highly competent team. Must be highly collaborative in approach but also able to put forward own point of view and establish credibility as a key team participant.
- Dedication and personal commitment combined with a pragmatic attitude to improvise and innovate when necessary
Qualifications
- Scientific Degree (Engineering/Physics/Maths)