Principal Systems Engineer, Product Design Owner (Medical Devices)

Location: Skaneateles, New York, United States

Salary: $112,000–$154,000 annually, with potential discretionary bonuses.

Company

hirify.global develops healthcare products and technologies focused on its mission to save and sustain lives.

What you will do

• Own and evolve product designs across the lifecycle of the Exam Diagnostics portfolio.
• Provide technical assessments, tradeoff analyses, and risk evaluations for product and business decisions.
• Lead technical decisions and alignment across engineering, quality, regulatory, manufacturing, service, supply chain, marketing, and program management.
• Lead design changes, technical reviews, and risk management under the Quality Management System.
• Resolve complex product, quality, manufacturing, and field issues while improving performance, reliability, manufacturability, quality, and cost.
• Support complaint investigations, supplier corrective actions, post-market activities, and engineering team mentoring.

Requirements

• Bachelor’s degree in Systems, Biomedical, Electrical, Mechanical, Computer, Software Engineering, or a related technical field.
• At least 5 years of experience in product development, systems engineering, sustaining engineering, or product lifecycle management in a regulated industry.
• Technical expertise across hardware, software, and integrated systems.
• Strong knowledge of Design Controls, Risk Management, Verification and Validation, and Product Lifecycle Management.
• Knowledge of FDA, ISO, IEC, GMP/QSR, and applicable design control requirements.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience as a Product Design Owner, Systems Engineer, Lead Systems Designer, Product Architect, or Technical Lead.
• Experience with post-market quality investigations, sustaining engineering, or manufacturing changes.
• Experience with connected medical devices, digital health, or software-enabled products.
• Advanced degree or relevant professional certifications.

Culture & Benefits

• Full-time employment within a global, matrixed organization.
• Medical and dental coverage beginning on day one, plus life, disability, and travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, ESPP, and flexible spending accounts.
• Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
• Additional commuting, childcare, employee discount, and employee assistance benefits.