Overview: We are currently looking for a Software Design Assurance Engineer / Software Quality Engineer to champion the Design Quality Assurance activities within the software group. You will provide guidance and hold the team to the quality standards required by the business, regulatory bodies and ultimately patients. Your broad knowledge of software quality principles and medical design controls, together with your energy and attention to detail will assure our mutual successes.
Duties and Responsibilities
- Work with the Software and Quality teams by continuously improving our QMS to ensure compliance with FDA regulations, as it relates to software.
- Participate in the creation, review, and maintenance of the DHFs for our device / system software and firmware.
- Participate in, and guide the software risk management activities, including Software FMEA and FTA processes, within the guidelines of the ISO 14971 standard.
- Support the SW QA team’s development of test protocols, test reports and traceability matrices.
- Support the creation and review of software requirements, V&V Plans, design documents and other design control documentation.
- Provide software team support for quality system activities such as audits, complaints and CAPAs.
- Bachelor’s degree in Computer Science, Computer Engineering, Biomedical Engineering or a related technical field.
- 4 years of experience in software quality and/or design assurance of FDA regulated medical devices.
- Experience working within the IEC 62304 SDLC standard, exposure to Agile methodologies using AAMI TIR45, and Risk Management with ISO 14971.
- Working collaboratively within software teams, demonstrating successful compliance to regulatory standards.
- A passion for quality in the medical device field.
- Experience working as a quality engineer on mobile, digital health and embedded software applications for medical devices.
- Strong knowledge of the application of regulatory requirements for the different risk levels of medical device software.
- Proven track record of making continuous improvements to the QMS, as it relates to software, including training and mentoring team members.
- Exceptional organizational and communication skills, as demonstrated by independently providing high quality deliverables.
- Experience supporting and/or participating in audits by regulatory bodies.
- Experience with quality systems software tool validation