Software QA Engineer 1

Role: Software QA Engineer 1

Software Design Assurance (Software Design Quality) Engineer providing technical support and guidance to software teams to ensure adherence to software development processes and applicable safety/quality regulations.

Responsibilities

• Serve as a core team member on the R&D Quality Assurance Engineering team.
• Provide strong guidance on software design assurance requirements and conformance to standards/regulations, including:
  • IEC 62304
  • 21 CFR 820
  • ISO 13485
  • ISO 14971 (where applicable)
• Lead effective application, compliance, and continuous improvement of policies/procedures/practices across software teams for software development and validation.
• Drive pre-market risk management deliverables such as:
  • SHA
  • Design FMEA
  • Support cyber security risk management
• Guide software design and test teams; support software configuration management, tool validations, and software integrations.
• Review and approve software design control deliverables.
• Support post-market activities related to software anomalies, risk assessments, and CAPA (if applicable).
• Lead/support R&D software design assurance continuous improvement efforts.
• Review, author, and revise technical documentation (e.g., design history files, SOPs, protocols, reports).
• Assess change control impact to ensure no adverse impact on product performance and continued compliance.
• Communicate plans, status, progress, and challenges to cross-functional teams and upper-level management.

Requirements

• Medical device experience with compliance to FDA 21 CFR Part 820 and IEC 62304, plus ISO 13485.
• Knowledge and experience with SDLC processes and software development methodologies (e.g., Agile Software Development, Waterfall).
• Software quality/engineering experience across requirements analysis, design/development, product integration, and test.

Nice to have / Additional context

• Ability to interpret software development processes and support cross-functional groups including Software Engineering/Test, Regulatory Affairs, Cybersecurity, Systems Engineering, Marketing, and Project/Senior leadership.