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Medical Device Standards and Regulatory Engineer

  • GE Healthcare
  • Experienced
  • Posted 2/1/2018 6:50:42 AM
  • 3048324
  • Job Function: Engineering/Technology
  • Business Segment: Healthcare Clinical Care Solutions
Location(s): United Kingdom; Sandiacre


About Us:
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
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Role Summary:
The Medical Device Standards and Regulatory Engineer will play a vital role within both new product introduction program teams and product Lifecycle support in the area of regulatory submissions, global standards compliance and design controls. The applicant will be part of a growing R&D team and will work with world-first product offerings in the fetal-maternal care segment primarily on wireless electronic transducers, ECG electrode patch technology and wireless communications/ interfaces.

Essential Responsibilities:

  • Utilize expertise in global medical regulatory standards to reduce overall global standards to actionable, quantifiable and testable technical product requirements. Arrange and manage testing for both new product regulatory submissions to 60601 and similar standards and to ensure ongoing compliance
  • Utilize expertise in global wireless standards compliance to arrange and manage testing for both new product regulatory submissions to FCC and RED standards and to ensure ongoing compliance
  • Drafting of all technical documentation to obtain FDA 510k clearance and CE marking technical files for new products including user manuals and labelling design
  • Take ownership of risk assessments
  • Act as a Design Control manager within new product teams to execute plans according to committed timelines and within regulatory and quality guidelines and processes to meet the team’s overall quality, deployment, performance and productivity goals
  • Actively manage compliance risk through appropriate metrics and other transparent operating mechanisms
  • Share expertise and institutionalize learnings through opportunities to provide training to technical and management teams
  • Maintain customer focus and product quality vigilance, including Quality Management System compliance


The role may require the applicant to travel, both within the UK and globally to other GE sites and regulatory bodies

Qualifications/Requirements:


Essential Requirements:


  • Bachelors degree or equivalent in Electronic or Biomedical Engineering or other relevant subject or equivalent knowledge and experience
  • Significant experience of preparing technical documentation for FDA 510k submissions, CE technical submissions, risk assessments to ISO 14971, medical device electrical safety testing to IEC 60601-1 and FCC/ RED wireless standards
  • Experience of working within design control processes and operating within quality systems like ISO 13485, FDA QSR and MDSAP
  • A motivated self-starter “doer” who takes responsibility to deliver projects on time
  • Experience of interacting with engineers, test houses, internal and regulatory affairs bodies, notified bodies and audit teams
  • Ability to communicate clearly and concisely at all levels of management


Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
http://www.ukba.homeoffice.gov.uk/visas-immigration/working

Desired Characteristics:


The ideal candidate will have:


  • Experience with medical products which include biomedical signal processing, lithium batteries, advanced wireless connectivity, Bluetooth, USB, touch sensor, LCD screens and ECG electrodes
  • Experience in an electronics manufacturing environment
  • Documentation with EN62304 for medical products (or similar industry quality standards)

    Locations: United Kingdom; Sandiacre

    GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.


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