Jobs

Mechanical Engineer - Permanent - Essex - Southern

Medical/Pharmaceutical - Research & Development
Ref: 444 Date Posted: Thursday 10 Jun 2021
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Summary of post:

Conceptualize, design and develop medical and non-medical components and devices/accessories through initial concept design, engineering analysis, prototyping, risk assessment and evaluation to realise the planned device portfolio

Principle Responsibilities:

  • Research, Design development and prototyping of products in accordance with company development standards (eg TDP, PDD) to meet functional, clinical, regulatory and manufacturing requirements
  • Technical approval for project and process output to ensure compliance with agreed specifications and all relevant regulatory standards
  • Research and maintain state of the art new product development, materials and manufacturing technologies including intellectual property and their application to meet or exceed customer company and project needs
  • Evaluation and documentation of the feasibility, reliability and risk of concepts and/or prototypes through engineering testing and analysis to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
  • Develop timelines cost and resource estimates for development tasks to appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule
  • Generate and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR) Good Manufacturing Practice (GMP), International Standards Ordinance (ISO) and in conformance to company development standards (e.g. PDD, TDP) throughout the product life cycle to ensure the design is fully documented
  • Progress vendor activities in agreement with global sourcing relative to communication of specifications, developments schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly
  • Deliver manufacturable designs acceptable to operations by applying design for manufacture principles and implement feedback from Manufacturing Engineers, external suppliers and other sources
  • Ensure high product and process quality in collaboration with the quality department and all other departments

Coordinate inbound and outbound projects and workstreams in collaboration with external partners (e.g. contract developer or contract manufacturer) , ranging from the definition of specifications, buying of products in collaboration with purchasing, technical assessment and testing of products and coordination of joint developments

Other Responsibilities:

  • Support the verification, evaluation and validation of product designs
  • Transfer product designs successfully into production
  • Produce, review and update Computer aided Design models, drawings and other company design data set up
  • Implement design change control procedure
  • Perform design analysis, e.g. tolerance analysis, product risk analysis, FMEAs, design reviews, value analysis and quality incident investigations
  • Use software analysis tools as appropriate to produce robust designs

Qualifications and Experience:

Education qualifications

  • Bachelors or master degree or ONC/HNC in Engineering or equivalent professional education or equivalent skill and knowledge gained through significant practical experience

Experience

  • Some years of experience in a regulated and highly industrial or scientific engineering design environment
  • Project experience
  • Experience and understanding of intellectual property

Specific skills

  • Experience in medical device development - preferred
  • Understanding of a wide range of engineering technologies used in design manufacturing
  • Strong problem solving skills
  • Understanding interfaces between functions, understanding of the needs of others

Job specific requirements

  • Educational Qualification in Mechanical Engineering or equivalent
  • Applied knowledge of Mechanical engineering principles, i.e. fluid/gas flow analysis & plastic material science
  • Applied knowledge of Manufacturing processes and materials, i.e. injection moulding, plastic extruding, vacuum forming
  • Proven experience of Mechanical product development of class II medical devices (e.g. indirect patient contacting devices and/or accessories used in the cleaning, disinfection & sterilisation of medical devices - preferred) to meet regulatory (including biocompatibility, CDS, sterile packaged devices) and user requirements and optimise for manufacture, e.g. DFMEA, user risk assessments, usability studies, verification activities with statistical analysis, conducting Design reviews, producing and approving DHF documents
  • Understanding of endoscopic procedures, particularly the irrigation, insufflation & suction aspects - preferred

 

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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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