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Senior/Software Design QE

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    Other Locations

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    Dustin Graham

  • Published

    26 days ago


Job Description

Position Summary:
As an integral member of the quality team, the Design Quality Assurance Engineer will provide Quality representation and guidance to R&D in supporting projects for new and existing products in accordance with applicable regulatory requirements. This person partners with R&D, Regulatory and Operations in the development, verification, validation and approval of products.
Foster a 'strong right first time' compliance culture.

Duties and Responsibilities:

  • Serve as a quality representative to R&D for all design controls and product development activities.
  • Ensure new products are developed per state-of-the-art standards.
  • Support design verification and validation, and review V&V test plans and reports to ensure the design outputs meet both system and customer requirements.
  • Participate in design and phase gate reviews at all phases of product lifecycle process.
  • Partner with internal customers to perform risk management activities including hazard identification, hazard analysis, DFMEA and risk mitigation consistent with ISO 14971.
  • Provide guidance to the software team on the application of IEC 62304 to all software.
  • Work closely with the NPI team to transfer design into manufacturing.
  • Collaborate with cross-functional teams including R&D, Manufacturing, Operations, Service to develop Device Master Records.
  • Audit DHFs to ensure compliance with Design Control Procedure.
  • Initiate, review and approve Document Change Orders and Engineering Change Orders.
  • Act as a technical resource to troubleshoot problems originating from customer complaints.
  • Participate in internal and external audits (FDA, Notified Body, etc.)
  • Develop standard operating procedures for processes in design controls as required.
  • Other duties as assigned.


  • Bachelor's degree in Science or Engineering or related discipline.
  • Minimum 3-5 years' experience working in a highly regulated medical device environment.
  • Detail-oriented with the ability to lead multiple projects and activities assigned.
  • Excellent organizational skills, planning, communication and follow up skills.
  • Proficient in Microsoft suite, SPC tools.
  • Ability to work in a fast-paced, team-oriented environment with strict deadlines.
  • Strong knowledge of design controls in medical device.
  • Working knowledge of applicable medical device regulations such as 21 CFR 820, ISO 13485:2016, ISO 14971:2019, EU MDR and MDSAP.
  • Experience with IEC 60601-1, IEC 62304 and IEC 62366 requirements.
  • Significant attention to detail and highly organized
  • Demonstrated oral, presentation and technical writing skills
  • Strong analytical skills