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R&D Development Engineer

Research & Development
Ref: 223 Date Posted: Wednesday 25 Jul 2018
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R&D Development Engineer

(Initial 6 month contract – potential to extend)

Excellent Hourly Rate

Southend-on-Sea

The Company

As part of a global manufacturing community, our client’s Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical products.  Working with colleagues in Europe, the USA and Japan, their multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical devices.  Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential.  Therefore, in today's fast moving, ever changing world, they continue to invest in both their people and the latest equipment and processes to remain at the forefront in manufacturing technology.

 

The Role

Working on Medical Device Research and Development, you will work in a creative environment and be encouraged to invent, innovate and revolutionise within a structured professional framework, whilst collaborating with industry experts, universities and third party specialists, to identify design requirements and pioneer product and technical solutions.

Due to the nature of the role you will ideally have experience of working within a regulated industry, and have a proven track record of working to regulatory standards, directives and requirements (e.g. ISO9001, ISO61010, RoHS, ISO13485, ISO14971, ISO60601, and ISO62366).

The company is globally recognised for producing ‘best in class’ medical devices and this reputation is built upon the exceptional work of their people.  Their standards are exacting and they take pride in their exemplary facilities and safety conscious environment.

 

Essential Skills

  • In depth understanding of medical device development process from concept to Production
  • Ability to manage the technical R&D aspects of the medical device development process from concept to Production
  • Gathering design requirements and defining technical parameters for medical device development, including assessing and understanding medical standards and regulations
  • Ensuring design requirements are met, including means such as mechanical engineering analysis, e.g. structural / fluid flow, and leading design reviews.
  • Leading the product design direction and design solution decisions.  
  • Undertaking product risk management activities, including DFMEA and user risk assessment.
  • Directing and undertaking usability / ergonomic / HFE / design validation studies with clinical users, prototype builds, prototype testing and final verification.
  • Maintaining the Design History File (technical design documentation)

 

Role Responsibilities

  • Mechanical design and development of medical products from concept through to repeated production 
  • Review, analyse and approve the product design
  • Compile technical documentation to support the design process
  • Assist with the management of work packages for new product development and product improvement projects
  • Use technical and product knowledge, along with problem solving abilities, to resolve technical and project issues
  • Researching new technologies
  • Conducting product risk analysis, FMEA’s and value analysis activities
  • Using software analysis tools to produce robust designs (e.g. FEA or CFD)
  • Deliver design and development work packages to fulfil specified requirements to planned timescales and cost
  • Translating inputs into robust Design Requirements
  • Applying mechanical principles and methodology to generate product solutions

 

Additional Role Responsibilities (Senior)

  • Acting as a Technical Lead on multi-disciplinary development teams
  • Mentoring / Coaching staff
  • Acting as an Independent Engineer within Project Design Reviews
  • Peer review of product design and technical documentation output
  • Leading continuous improvement activities within the R&D Dept.

 

Personal Abilities

Required

  • A degree or equivalent in an appropriate engineering or scientific discipline
  • Good design practice and experience of Design Transfer into production manufacturing
  • Excellent understanding of Mechanical engineering principles
  • Self-motivation, with an innovative approach to problem solving
  • Exceptional levels of teamwork and cooperation
  • Tenacity and a commitment to seeing tasks through to completion
  • Experience of developing Medical Devices; or products from a highly regulated industry
  • Experience of the full product development lifecycle, including an appreciation of Design Verification & Validation
  • Applied knowledge and experience of good design practice & mechanical engineering principles (e.g. materials, structures, thermal analysis, fluid analysis, tolerance analysis) and a variety of manufacturing processes (e.g. machining, sheet metal, injection moulding, casting and extruding) are essential
  • Experience in mechanical design or (Preferable) plastics injection moulding and/or extruded components.
  • A proven ability to apply engineering principles.
  • Ability to generate test plans and technical reports to a standard that will pass scrutiny against the BS EN ISO 13485 standard and the FDA’s 21 CFR part:820 regulations.
  • A genuine passion for engineering and for achieving reliable, high quality, cost effective designs.
  • Relocation assistance is available if required.

 

Desired

  • Areas of medical knowledge:
  • ETO sterilisation,
  • biocompatibility,
  • cleaning and disinfection
  • Serial production medical devices for products that interact with end users
  • (Preferable) Hands-on experience of 3D CAD. (Solidworks preferred)
  • (Preferable) Knowledge of sterilisation processes and standards.

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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