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Medical Device Engineer

Ability Resourcing
Job LocationCambridge
EducationNot Mentioned
Salary£40,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Medical Device EngineerA perfect opportunity for an experienced Medical Device Engineer to have an impact on a medical device product in the company, that is featured in the Sunday Times Tech Track 100 and is rapidly growing after the increased adoption of their ground-breaking technology for improved cancer care.This is an opportunity for an enthusiastic, hands-on Medical Device Engineer to join this growing Product Engineering team, where you will have a great impact on medical product development.CompanyThe Company is a medical device developer that believes everyone deserves a better standard of cancer care. Many of the world’s leading physicians and hospitals use their medical devices to help patients with breast cancer avoid unnecessary surgery and experience better outcomes.So far, the team has helped tens of thousands of women around the world access more precise and less invasive breast cancer care. The company is developing a range of new products to maintain its market-leading position, and is growing the R and D team to support these developments. This role is a critical part of the R&D team and the company is seeking driven, creative, communicative team members to help continue to deliver this promise. We are looking for Medical Device Engineer who is passionate about product development and has the skills and ambition to help us make a difference.The roleThe role will offer you the opportunity to support and lead on projects as a part of the development of company’s future implantable products. As a part of their multi-disciplinary team your technical knowledge and creativity to offer innovative solutions will lead to product demonstrating real clinical benefit for patients and clinical users.Their cutting-edge medical device products are developed and manufactured in collaboration with a network of third-party suppliers, contract development organisations, and consultants who work alongside company’s R&D team.You will contribute to multiple projects and coordinate with the other members of the R&D team and wider groups at the company.They are certified to ISO 13485 and product development activities will need to be operated and documented to relevant medical device standards.Key Responsibilities

  • Manage and support the engineering design and development of new medical device products at various stages of development;
  • Generate concepts and detailed design considering design for manufacturing; design for high reliability based on engineering analysis; design of experiments;
  • Develop and document design requirements; lead design reviews and compile Design History and Technical Files that comply with company’s ISO13485 Quality Management System;
  • Manage risks and document risk management according to ISO14971 using techniques such as Hazards identification, risk analysis and evaluation, and design and process FMEA;
  • Develop and execute verification and validation test procedures, and test reports;
  • Work in a team environment; peer review work;
    • You should apply for the role of Product Quality Engineer if you:
  • have a degree in Engineering, science or related subject or similar discipline
  • have 3-5 years in medical device development ideally within implantable devices.
  • Experience in aspects of concept generation; engineering analysis and detail design; and formal testing as a part of new product development.
  • Experience in writing technical documentation as a part of regulatory submissions such as Technical File or DHF.
  • Experience in the management of external design consultants, suppliers and subcontractors
    • Desirable Experience:
  • Experience with CAD would be beneficial.
  • Knowledge of manufacturing techniques ideally with experience of transfer to manufacture.
  • Understanding of global medical device regulations, requirements, and standards. Abilities and Skills.
  • Proven project management, organisational and time management skills.
  • Excellent written and presentation skills communicating technical requirements, issues and solutions.
  • Well-organised with the ability to work with critical attention to detail and high levels of accuracy.
  • Self-motivated and able to manage own workload.
    • OtherWillingness to travel within the UK and internationally.This is a great opportunity for a person with several years of experience in medical device engineering to join this expanding team - this company are positioned to more than double in size in the near future, and so this is an opportunity to develop and become integral to their core team. In this role you will use your skills and knowledge in medical device engineering to make a difference in people’s lives who are battling cancer. Required skills
  • CAD/CAM
  • CAE
  • Engineering Discipline
  • Implantation
  • Medical Devices

    • Keyskills :
    CAD/CAM CAE Engineering Discipline Implantation Medical Devices

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