Principal Risk Engineer

About the role

The Risk Engineer is responsible for leading and executing risk management activities for infusion pump systems through the product lifecycle. This role ensures patient and user safety by identifying hazards, assessing risks, and implementing effective mitigation strategies in compliance with corporate procedures and industry standards (e.g., ISO 14971) by working with engineering, quality, regulatory, clinical, manufacturing, and service teams to integrate risk management into product design, development, and post-market activities in support of ongoing product safety.

Responsibilities

• Lead risk management activities in accordance with ISO 14971 and corporate procedures related to risk management plans, hazard analyses, FMEAs, fault tree analyses, and risk reports
• Identify hazards associated with infusion pumps, including mechanical, electrical, software, usability, and cybersecurity-related risks
• Collaborate with cross-functional teams during design and development to ensure risk controls are incorporated and verified and/or validated
• Ensure traceability between hazards, hazardous situations, risk controls, and verification activities
• Perform robust risk impact assessments of issue records, change controls, complaint trends and NCR/SNCs and other scenarios using appropriate severity and probability models and ensure risks are reduced to acceptable levels or provide decision support to management or post-market monitoring
• Update risk management files based on design changes and post-market information and ensure ongoing product safety
• Facilitate risk reviews and risk management team meetings
• Train and mentor team members on risk management principles and tools

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Systems Engineering, Computer Science or related field)
• 5+ years (senior-level) experience in medical device risk management or product development
• Working knowledge of ISO 14971 and related standards
• Experience with risk analysis tools (e.g., FMEA, FTA, hazard analysis), bug tracking tools, requirements management tools (e.g. DOORS) and traceability, and documentation.
• Excellent analytical, problem-solving, and communication skills
• Ability to manage multiple priorities and project schedules

Qualifications

• Must be authorized to work for any employer in the U.S.

Skills

• Strong understanding of medical device regulations and standards
• Proficiency in risk assessment methodologies
• Experience with medical device design and development processes
• Excellent interpersonal and communication skills
• Ability to work effectively in a team environment

Benefits

• Comprehensive compensation and benefits packages including medical and dental coverage, insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance, the Employee Stock Purchase Plan (ESPP), and the 401(k) Retirement Savings Plan (RSP).
• Flexible spending accounts, educational assistance programs, time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Pay

The estimated base salary for this position is $112,000 to $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Schedule

The schedule for this role is typically full-time.