Systems Engineer, Verification & Validation (Medical Devices)

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

Salary: $77,300–$116,000 annual base salary for U.S.-based positions, with potential incentive compensation

Company

hirify.global is a medical device company developing the Omnipod platform for insulin delivery and other subcutaneous drug-delivery applications.

What you will do

• Lead verification and validation activities and deliverables for new product development and sustaining products.
• Develop verification and validation plans, schedules, requirements analyses, test cases, and test runs using DOORS, Helix, and Jama.
• Create, execute, and maintain robust system-level test methodologies, including dry runs, regression testing, typical-use scenarios, edge cases, alternate paths, and negative paths.
• Manage third-party verification activities and support compliance with applicable IEC, AAMI, and UL 60601 standards.
• Maintain product configuration management and provide technical recommendations for product and design changes.
• Mentor early-career test-team members and collaborate with systems engineering, development, regulatory, quality, procurement, and manufacturing teams.

Requirements

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical Engineering, Electrical Engineering, or a related field.
• At least 3 years of experience testing medical devices in a multidisciplinary project environment, or an advanced degree with at least 1 year of experience.
• Experience with verification and validation test programs, system-level testing of software-based medical devices, and requirements-driven test-case development.
• Experience with FDA-regulated Class 2 or 3 medical devices, Design Controls, and Quality Management Systems.
• Knowledge of standards including ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Strong technical judgment, analytical and problem-solving skills, communication skills, and experience leading cross-functional teams.

Nice to have

• Familiarity with JIRA, Confluence, and Bamboo.
• Test engineering training or certification.
• Experience directing associates and leading small cross-functional teams.

Culture & Benefits

• Hybrid working arrangement with required on-site work.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Work in a fast-paced medical-device R&D environment focused on diabetes care innovation.