Principal Systems Engineer (Medical Devices)

Location: Onsite in North Haven, Connecticut, United States; limited travel may be required.

Salary: $134,400–$201,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including products for surgical procedures, wound management, and hernia repair.

What you will do

• Lead systems engineering activities across wound management and hernia product families throughout the product lifecycle.
• Define intended use, use cases, stakeholder needs, design inputs, and end-to-end requirements traceability.
• Assess the impact of design, process, material, manufacturing, and labeling changes on launched products.
• Drive technical investigations, root cause analyses, and cross-functional problem-solving.
• Evaluate system-level risks, tradeoffs, design decisions, customer needs, and manufacturing feasibility.
• Mentor engineers and provide technical guidance on systems engineering processes, tools, and deliverables.

Requirements

• Bachelor’s degree with 7+ years of relevant engineering experience, master’s degree with 5+ years, or PhD with 3+ years.
• Experience performing systems engineering in a regulated product development environment, including requirements management, risk management, verification, and validation.
• Experience with design controls and lifecycle activities for commercialized products.
• Experience leading technical projects and influencing cross-functional stakeholders.
• Ability to work onsite in North Haven, Connecticut.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Degree in Systems Engineering, Biomedical Engineering, Materials Science Engineering, Mechanical Engineering, or a related discipline.
• Medical device industry experience, especially with wound management, sutures, needles, mesh, or consumable products.
• Experience supporting high-volume product families with many configurations, SKUs, or variants.
• Experience with requirements traceability, risk analysis, and model-based systems engineering.
• Experience supporting released products through design changes, product improvements, technical investigations, and manufacturing or quality initiatives.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and long-term disability coverage.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance or reimbursement, employee stock purchase plan, and employee assistance program.
• Equal employment opportunity and reasonable workplace accommodations.