Vacancy: United Kingdom

RA Officer

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.

A further requirement of the role will be to work closely with the QA team to participate in post-market surveillance activities and to collaborate in the investigation and rectification of emergent failure modes.

Vacancy

Role

The Senior Product Engineer 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.

Given the virtual manufacturer nature of Endomag, 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.

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

Qualifications

  • Degree or equivalent in physics/engineering or closely related field

Experience and knowledge

  • 10+ years’ experience in high-tech engineering to exacting standards
  • Customer-facing and supply-chain management experience
  • Track record of taking products from R&D through to commercialisation
  • Problem solving methodology (8D, 5 Whys)
  • Statistical Process Control
  • Excellent IT skills (MS Office)
  • ISO 13485 experience would be beneficial

Abilities and skills

  • Self-starter, team and consensus builder, strong motivational skills
  • Excellent written and presentation skills, demonstrated in a wide range of contexts
  • Evidence of effective communication, negotiation and inter-personal skills
  • Innovative strategic planning and excellent problem-solving skills
  • Evidence of ability to work with critical attention to detail and high levels of accuracy
  • Proven excellent organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met

How to apply

Applications

To apply for this role, please email:

recruitment@endomag.com

Please attach a cover letter and CV/resume.