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

- Demonstrated leadership and experience in risk management. - Strong understanding of medical device regulations and standards. - Proficiency in risk assessment methodologies and tools. - Excellent interpersonal and communication skills. - Ability to work effectively in a multidisciplinary team environment.

Skills

- Risk management expertise. - Knowledge of medical device regulations and standards. - Proficiency in risk assessment methodologies and tools. - Strong analytical and problem-solving skills. - Excellent communication and interpersonal skills. - Ability to manage multiple projects simultaneously.

Benefits

- Comprehensive health and well-being benefits. - Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. - Financial and retirement benefits including the Employee Stock Purchase Plan (ESPP) and the 401(k) Retirement Savings Plan (RSP). - 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 including commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Pay

- Estimated base salary range: $112,000 to $154,000 annually.

Schedule

- Flexible workplace policy with a required minimum number of days a week onsite.