Jobs

Product Design Engineer - UK

Design
Ref: 292 Date Posted: Monday 05 Aug 2019
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MAIN PURPOSE OF JOB ROLE:

Position is responsible for providing product design, robust development and engineering expertise in the field of NPD (New Product Development), creating and developing designs within the design DNA framework, innovating using state of the art techniques to produce products which meet identified customer needs. Also, to carry out mechanical design development, tooling development through to validation of final product for FDA submission and CE marking.

 

SCOPE OF ACCOUNTABILITIES:

  • Concept Generation: contribute to the concept generation process by producing ideas to solve complex user/engineering issues.
  • Specification development: liaise within project team to develop product specifications.
  • Design Development: Maintain ownership of the design through the development process and into production, when required. Will be comfortable and confident working in a broad range of production processes and materials.
  • CAD Development: Create, develop ideas and/or maintain designs in development using 3D CAD software (Solidworks) in line with the project key milestones and the quality framework. 
  • Tooling Development: Carry out assessments of potential tooling partners for prototype and production tooling in accordance with the project milestones and organise procedures for manufacturing trial batches. Work with the quality team to deliver validated processes.
  • Mechanical analysis: Using appropriate methods perform mechanical analysis of the design/s to achieve robustness in operation and production in line with end user needs and the quality plan. 
  • Verification/Traceability: You must maintain accurate and up to date records of all work carried out in accordance with the quality team/regulatory requirements. Write test protocols and undertake development and verification testing.
  • Risk Analysis:  Participate or lead risk analysis activities through the full duration of a project, ensuring accurate documentation and successful conclusion of identified actions.

 

 

Compliance

  • Ensure compliance with internal standards and global regulations
  • Develop product documentation in accordance with company procedures
  • Establish and maintain procedures for new product development in compliance with regulatory requirements FDA 21 CFR 820 and CE. FDA 21 CFR 11 and ISO:13485

 

Communication and liaison

  • Teamwork: Integrate quickly into the company, forming good relationships within the team, across department and with co-workers within the company family including science, quality, clinical and marketing and manufacturing functions.  Work cooperatively within an R&D team, sharing ideas and concepts to enable achievement of goals.  Develop skills and understanding in less experienced team members. 
  • People: Transfer knowledge relating to particular product development to peer group as and when required.
  • Outsourcing: Liaise/manage with external companies regarding supply of materials or services.
  • Communication: Written reports and verbal presentation of findings/designs is key to help build a well informed and highly autonomous project and business team. Therefore, you are required to prepare reports and create presentations to communicate findings/designs within the company.

 

Innovation:

  • Develop and deliver innovative mechanical design solutions.
  • Develop and improve current technologies and protect proprietary inventions by working with IP team to file patent applications. Follow up on new inventions to deliver patentable solutions to problems.

 

Environment/culture:                                                                                                                                                           

  • Work within a culture in which you accept responsibility of your own development.
  • The jobholder must be receptive to working in a fast-paced, constantly changing work environment that demands they step out of their comfort zone on a day-to-day basis. 
  • The jobholder must be prepared to travel worldwide (inc. extended periods) when required to liaise with local manufacturing partners in the transfer of products into production.

 

PERFORMANCE CRITERIA – How will my progress be measured?

  • Ability to correctly identify and capture requirements.
  • Development and testing of ideas/development and pilot production solutions.
  • Timely (parallel) development of user/mechanical specifications

 

 

KNOWLEDGE AND EXPERIENCE:

  • Proven track record of developing products from concept and delivering into production in accordance to their relevant regulatory standards, preferably within the medical device arena.
  • Proven track record in solving user/mechanical problems.
  • Demonstrable experience of production scale up, robustness and validation studies.
  • Detailed understanding of the NPD (new product development) process and demonstrable experience of using mechanical design and development tools.
  • Ability to manage external suppliers and technical partners.
  • Degree qualified in Product Design Engineering / Mechanical Engineering or equivalent commercial experience considered.

Specialists in consultancy


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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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