Senior Systems Engineer (Medical Devices)

Location: Hybrid — requires on-site work from an hirify.global office in Acton, Massachusetts, United States

Salary: $102,400–$153,550 annual base salary for U.S.-based positions, with potential incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable subcutaneous drug-delivery technologies.

What you will do

• Lead and contribute to systems engineering activities across product design changes, integration, characterization, and lifecycle support.
• Refine requirements, analyze product architecture, conduct risk reviews, implement mitigations, and develop system verification plans.
• Perform functional and timeline analyses, trade-off studies, system troubleshooting, and root cause investigations.
• Lead hazard identification and FMEA activities throughout the product lifecycle.
• Develop and execute system integration, verification, validation, and safety testing, including analysis and documentation of results.
• Support post-market surveillance, customer complaint investigations, manufacturing changes, regulatory documentation, audits, and cross-functional technical decisions.

Requirements

• Bachelor’s degree in engineering, biomedical, electrical, mechanical, systems engineering, or a related field.
• 6+ years of experience in systems engineering within product development and 4+ years in the medical device or another highly regulated product development industry.
• Experience with system-level design, requirements management, architectural development, and systems verification and validation.
• Strong knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 60601.
• Experience with requirements management software such as Jama, Polarion, or DOORS.
• Strong analytical, problem-solving, communication, collaboration, organizational, and documentation skills.

Nice to have

• Master’s degree in engineering, a related field, or engineering management.
• Experience managing multidisciplinary programs or projects from development through commercialization.

Culture & Benefits

• Work with electrical, software, mechanical, manufacturing, quality, regulatory, and other cross-functional teams.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Technical mentorship and collaboration across global teams.