Systems Engineer (Medical Devices)

Location: Hybrid in Acton, Massachusetts, United States

Salary: $81,700–$122,500 annual base salary, plus potential incentive compensation

Company

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

What you will do

• Support the design, development, sustaining, and quality processes for wearable medical devices throughout the product lifecycle.
• Lead root-cause investigations, risk evaluations, design change assessments, field investigations, and post-market quality initiatives.
• Manage escalations and inquiries from field-facing partners and communicate findings to internal issue-management teams.
• Collaborate with Customer Support, Product Support, Software Development, Product Management, Quality, and Systems Engineering teams.
• Design and set up laboratory feasibility tests, author protocols and reports, and manage engineering build requests and materials.
• Execute design verification testing supporting design improvements, FDA and international clearance, and commercial release.

Requirements

• Bachelor’s degree in an engineering discipline, such as Biomedical Engineering or Computer Science.
• At least 2 years of experience as a Systems Engineer or Project Engineer in the medical device or another regulated industry, or equivalent experience.
• Ability to work in a fast-paced, dynamic environment with a commitment to continuous learning.
• Technical writing and effective communication skills.
• Experience with laboratory testing equipment.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Passion for improving patients’ lives.
• Ability to sit or stand for 8 hours per day.

Nice to have

• Experience with Software as a Medical Device (SaMD).
• Knowledge of engineering principles, scientific methods, medical device risk, issue management, and regulations.
• Systems-thinking and structured problem-solving skills.
• Experience troubleshooting complex systems involving hardware, software, mobile, cloud, connectivity, and third-party components.
• Experience analyzing diagnostic logs, telemetry, system events, or large technical datasets.
• Knowledge of cloud systems, mobile technologies, APIs, wireless communications, and connected IoT systems.
• Experience with AWS, Microsoft Azure, data analysis tools such as MATLAB, Minitab, or Power BI, and lifecycle tools including Jira, Helix, Bamboo, Bitbucket, or Polarion.
• Planning, organization, prioritization, and willingness to challenge designs.

Culture & Benefits

• Hybrid work arrangement.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and employee wellness programs.
• Performance-driven environment focused on customer expectations and improving patients’ lives.