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Product Quality Engineer

Job LocationCambridge
EducationNot Mentioned
Salary£40,000 - £50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Product Quality Engineer - Medical DevicesA perfect opportunity for an experienced Product Quality 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 Product 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. Now they are looking for driven team members to help continue to deliver this promise and play a critical role in building the Product Engineering Team. We are looking for Product Engineer who is passionate about product development and improvement and has the skills and ambition to help us make a difference.The roleAs the Product Quality Engineer you will work primarily within the Product Engineering Team but will have key working relationships with the QA/RA and R&D departments, supporting products that have been released to the field. Another aspect of the role will be to take emergent products from R&D and support transfer to manufacturing partners. This may require identification of new supply chain and will require providing input into the latter stages of Design History Files.This position plays a critical role for the business by investigating customer feedback and performing product performance monitoring and trending. In this role you will conduct product performance investigations that will lead to design, manufacturing and use improvements.You will be working closely with the QA team to participate in post-market surveillance activities and collaborate in the investigation and rectification of emergent failure modes.Given the virtual manufacturer nature of the company, a necessary part of this role will involve supply chain interaction; ensuring that suppliers continue to deliver product to acceptable quality standards and tracking of products with customers (via distribution partners) where it relates to performance, product quality and post-market surveillance.Key Responsibilities

  • Support the transfer of new products from R&D to manufacturing partners ensuring quality standards are met
  • Investigate emerging trending issues with products and work with manufacturers to resolve and address
  • Work with manufacturing partners to improve existing products
  • Work with supply chain to ensure product is supplied to stringent quality levels
  • Work with QA team to investigate quality incidents
  • Work with RA team to update post-market surveillance
  • Support regulatory submissions through compilation of design history files (particularly later stages), device manufacturing records and regulatory documentation
  • You should apply for the role of Product Quality Engineer if you:
  • have a Degree or equivalent in physics/engineering or closely related field
  • have several years’ experience in high-tech engineering to exacting standards
  • Problem solving methodology (8D, 5 Whys)
  • Knowledge in Statistical Process Control
  • Have excellent IT skills (MS Office)
  • Have customer-facing and supply-chain management experience (desirable)
  • Are a self-starter, team and consensus builder and have strong motivational skills
  • Have excellent written and presentation skills, demonstrated in a wide range of contexts
  • Show evidence of effective communication, negotiation and inter-personal skills
  • Have innovative strategic planning and excellent problem-solving skills
  • Are able to work with critical attention to detail and high levels of accuracy
  • Have proven excellent organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
  • OtherWillingness to travel within the UK and internationallyThis is a great opportunity for a person with years of experience in product engineering (preferably in medical devices) 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 product engineering to make a difference in people’s lives who are battling cancer.Join our team, and know that what you do today, matters today! Required skills
  • Data Analysis
  • Mechanical Engineering
  • Product Development
  • Product Engineering
  • Keyskills :
    Data Analysis Mechanical Engineering Product Development Product Engineering

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