Medical Devices Electronics Engineer

3 weeks ago

Oxfordshire, United Kingdom OrganOx Full time

Do you want to grow your career with an innovative, fast-paced and rapidly growing medical device company? OrganOx is committed to developing products that save lives by making every donated organ count. Our dynamic team strive to achieve excellence in the field of organ transplantation and you could be part of our exciting journey.

OrganOx is in the process of expanding its engineering capability and is seeking an experienced Medical Device Electronics Engineer to join the Product Engineering team.

As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range in the following areas:

  • Lead root cause analyses of field performance issues . Manage, and qualify electronics and system design changes to support improved manufacturing yield or system performance. This will require close partnership with field-based customer service, operations, and quality teams.
  • Implementing, and verifying design changes relating to product enhancements, and new features and functionality requested by clinical customers .
  • Resolving component obsolescence issues on the existing OrganOx product.
  • Supporting the creation of assembly and test instructions and outputs required by the Operations team, to ensure the transfer of electronics designs to production are delivered in accordance with design change and operational SOPs.
  • Working closely with Product Development and Innovations teams throughout development projects with a focus on supporting electronics design reviews and design transfer activities.

The position of Medical Device Electronics Engineer will be responsible for the design and maintenance of electronics designs within OrganOx’s existing product range. The successful candidate will have a track record of circuit design and layout for high efficiency, low noise systems.

The successful candidate will work within a small, multi-disciplinary team of engineers, including mechanical, test and software development. They will develop test protocols for design verification. They will support the wider team in ensuring compliant design and verifying performance, including travel to test facilities as part of EMC testing when required. The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities.

Skills, Experience & Qualifications:

  • Proven track record in the design, development, implementation, and validation of electronics for medical devices or other complex high integrity products.
  • Proven track record of electronics design and development compliant with ISO 13485 and ISO 14971.
  • Familiarity with the regulatory requirements for electrical safety for compliance with European, Canadian and United States quality standards, with practical working knowledge of IEC 60601 and ISO 13485.
  • Experience of version control systems (Altium, PDM) for electronics design highly desirable.
  • Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English
  • Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team
  • Comfortable with the dynamics and pace of change at a rapid growth start-up
  • Ability to work effectively with outside suppliers and manufacturers
  • Ability to work across multiple projects simultaneously
  • A first degree or equivalent qualification/experience in Electronic Engineering (Essential)
  • 5+ years of experience of working in a similar role.

We recruit and retain the best people from a broad range of diverse backgrounds who share our values of innovation, evidence, integrity, teamwork, respect and passion. If this sounds like you, and you’re looking for somewhere to grow, develop and thrive, we want to hear from you.

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