Principal Systems Engineer/PDO (Medical Devices)

Location: Round Lake, Illinois, United States; hybrid work with a required minimum number of onsite days each week.

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

Company

hirify.global develops healthcare products and infusion therapy solutions focused on saving and sustaining lives.

What you will do

• Lead interdisciplinary design and development of infusion pump systems combining electromechanical hardware, embedded software, and user interface components.
• Own product requirements, system architecture, interfaces, design realization, and end-to-end traceability.
• Make final technical decisions, lead trade-off analyses, and identify and mitigate technical and product risks.
• Drive design reviews, design changes, product risk files, and compliance with PDLM processes.
• Collaborate with engineering, manufacturing, regulatory, clinical, and commercial functions throughout the product lifecycle.
• Prepare DHF documentation and technical content for audits and regulatory submissions.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Software, or a related engineering discipline.
• 5+ years of engineering experience, including experience with products under design control.
• Good working knowledge of medical device regulations and standards.
• Experience leading the transfer of at least one project.
• Applicants must already be authorized to work for any employer in the United States.
• Visa sponsorship or transfer of employment visa sponsorship is not available.

Nice to have

• At least 5 years of relevant experience in the medical device manufacturing industry.

Culture & Benefits

• Flexible workplace policy supporting onsite collaboration.
• Medical and dental coverage beginning on day one for eligible employees.
• 401(k) retirement savings plan with contribution and matching options.
• Employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, paid time off, family and medical leave, and paid parental leave.