Sr. Software Developer Quality Engineer (Medical Devices)

Location: Hybrid with a minimum of 3 days onsite in Andover, Massachusetts, or remote within the United States. The posting also lists Burlington, Massachusetts.

Base compensation: $68,911–$150,350 per year.

Company

hirify.global Engineering provides engineering, software, R&D, and technology transformation services across multiple industries, including medical devices.

What you will do

• Ensure software design-control compliance throughout planning, development, verification, validation, transfer, and change management.
• Establish and maintain DHF, DMR, and DHR documentation with traceability from user needs through verification and validation evidence.
• Lead risk-management activities, including hazard analysis, FMEA, risk files, and integration of risk controls.
• Provide quality oversight of software SDLC activities in alignment with IEC 62304 and system-level risk management.
• Review design, software, and validation deliverables for completeness, consistency, and audit readiness.
• Support design transfer, CAPA, nonconformance investigations, root-cause analysis, audits, and regulatory submissions such as IDE and PMA.

Requirements

• Bachelor’s degree in business, engineering, project management, computer science, or a related discipline.
• 10+ years of software quality assurance experience in regulated environments, preferably medical devices.
• Embedded development or digital platform background, preferably involving Class II or III medical devices.
• Experience with IDE, PMA, or similar regulatory pathways and clinical evidence requirements.
• Strong knowledge of SDLC, design controls, traceability, DHF, risk-based software verification and validation, and FDA expectations.
• Familiarity with FDA regulations and standards including 21 CFR 820, 812, and 814, plus experience with test management, defect tracking, and quality documentation tools.

Culture & Benefits

• Permanent, full-time employment for experienced professionals.
• Paid vacation, company holidays, personal days, and sick leave.
• Medical, dental, and vision coverage, with benefits determined by local policy and eligibility.
• Retirement savings plans, including 401(k) in the United States.
• Life and disability insurance and employee assistance programs.