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R&D Mechanical Development Engineer

Research & Development
Ref: 263 Date Posted: Tuesday 30 Oct 2018
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On behalf of our global client, we are looking to recruit a Mechanical Engineer on a contract basis located at their Essex facility.

Key Result Areas

The role will be responsible for the risk analysis of the existing product range, including validation processes and test. Depending on the outcome of the risk analysis, there may also be a requirement for Engineering Change Requests (ECR) and labelling updates and instructions for use amendments.

The ideal candidate will have a minimum of 8 years' experience in Medical Device Development, specifically the full product development lifecycle. Particularly experience of product validation and test protocols. This role is largely paperwork based ensuring compliance of existing product range against upcoming changes to the Medical Device Regulations, although there will be 'hands on' mechanical engineering required relating to the design of test rigs and some CAD. A good understanding of how medical devices are used, (usability) and biocompatibility would be very helpful.

Product range includes; Medical Workstations, Carts, flushing pumps, ultra-sonic cleaning and tube sets.

Principal Responsibilities 

  • Support the development of the manufacturing business
  • Mechanical design and development of products according to company procedures and regulatory standards
  • Create and maintain product definition information in accordance with company procedures
  • Review, analyse and approve the product design
  • Compile technical documentation required by design control procedures 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 and problem solving abilities to support other team members and other departments
  • To liaise and co-operate fully with management for the better performance of the department and organisation.

Other Related Duties 

  • Undertake technical research, including competitor analysis to support design, development and manufacture of products
  • Utilise creative thinking to develop ideas which may lead to Patents or Registered Designs
  • Assist with proposals for new technology introduction and product development
  • Develop detailed designs from initial concept ideas
  • Design for manufacture
  • Produce product cost estimates
  • Undertake or supervise prototype and initial production builds and source components
  • Support the verification, evaluation and validation of product designs
  • Transfer product designs successfully into production
  • Produce, review and update 3D CAD models, drawings and other company design data set up
  • Implement design change control procedure
  • Performing tolerance analysis, product risk analysis, FMEAs, design reviews, value analysis and quality incident investigations
  • Use software analysis tools as appropriate to produce robust designs, for example FEA or CFD analysis
  • Provide assistance in producing plans for timescales, costs and resource estimates and monitoring progress against the plans
  • Lead design activities on Mechanical Engineering and design tasks
  • Coordinate various project activities within R&D and with other internal departments
  • Deliver project deliverables within planned project & product cost constraints and timescales
  • Assistance to production, manufacturing engineering, quality, regulatory affairs, technical publications, service, business development and sales
  • Contribute to the detection and elimination of all potential product quality or service concerns
  • Participate in Continuous Improvement activities
  • Undertake any assignment or duty as required by business needs
  • Provide assistance to the group

Qualifications and Experience

ONC/HNC in Mechanical Design or equivalent

Applied knowledge of:

Good design practice and Engineering Change Control

- Mechanical engineering principles, e.g. materials, structures, thermal analysis, fluid analysis

- Microsoft Office and Product Data Management (PDM) systems

- Manufacturing processes and materials, e.g. machining, sheet metal, injection moulding, casting, extruding.

- Industrial - Relevant regulatory standards – ISO9001, ISO61010

- Industrial - Relevant regulatory directives and requirements – RoHS, WEEE, EMC, LVD

- Medical - Relevant regulatory standards – ISO13485, ISO14971, ISO60601, ISO62366 (preferred)

- Medical - Relevant regulatory directives and requirements – US and EU medical directives, RoHS, WEEE, China and Japan medical directives, EMC, LVD (preferred)

- Microsoft Project (preferred)

Proven experience of:

- Technical research

- Application of Mechanical Engineering principles

- Mechanical design to meet design requirements and optimise for manufacture 

- Generating ideas and selecting the best way forward according to requirements

- Problem solving

- Conducting and reporting on Quality Investigations (preferred)

- Structural mechanics, fluid mechanics, electro-mechanical or optical products (preferred)

- CFD and/or FEA (preferred)

- Industrial – Design and Development of Industrial / Video Devices

- Medical – Design and Development of Medical Devices

- Working in a highly regulated and audited environment

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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