Principal Risk Engineer (Medical Devices)

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

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

Company

Develops healthcare technologies and medical devices supporting the mission to save and sustain lives.

What you will do

• Lead risk management activities for infusion pump systems throughout the product lifecycle.
• Develop and maintain risk management plans, hazard analyses, FMEAs, fault tree analyses, and risk reports in accordance with ISO 14971 and corporate procedures.
• Identify mechanical, electrical, software, usability, and cybersecurity-related hazards and define effective risk controls.
• Work with engineering, quality, regulatory, clinical, manufacturing, and service teams to integrate, verify, and validate risk controls.
• Assess issue records, change controls, complaint trends, and nonconformances using severity and probability models.
• Facilitate risk reviews, maintain risk management files, and train or mentor team members.

Requirements

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science, or a related field.
• 5+ years of experience in medical device risk management or product development.
• Working knowledge of ISO 14971 and related standards.
• Experience with FMEA, fault tree analysis, hazard analysis, bug tracking, requirements management tools such as DOORS, traceability, and technical documentation.
• Strong analytical, problem-solving, communication, prioritization, and project scheduling skills.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Culture & Benefits

• Flexible workplace policy combining remote flexibility with in-person collaboration and required onsite attendance.
• Medical and dental coverage beginning on day one, plus life, accident, disability, and business travel insurance.
• 401(k) retirement savings plan with company matching and an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, employee discounts, and employee assistance programs.