Senior Software Safety Engineer – Cardiac Medical Devices

Grove Technical Resources, INC; Mounds View (MN); On-site; USD 100,000 - 130,000; Part time

Job summary

A leading medical device company is seeking a Senior Software Safety Engineer to enhance safety and reliability in cardiac rhythm management products. This role involves conducting safety assessments, risk analysis, and compliance with global standards. The ideal candidate will have a degree in a technical field and at least 4 years of experience in software safety within regulated environments. This position is fully onsite in Mounds View, Minnesota.

Qualifications

• 4+ years of experience in engineering, quality, software safety, or reliability.
• Experience in regulated medical device environments, preferably implantable devices.
• Strong knowledge of software risk management and released product support.

Responsibilities

• Lead software safety and patient risk assessments for cardiac medical devices.
• Develop and maintain risk management files aligned with regulatory standards.
• Perform hazard analysis, risk severity assessment, and risk-benefit evaluations.
• Support verification, validation, and traceability activities.
• Investigate system failures, hazards, and corrective actions.
• Drive reliability studies, DOE, and process improvement initiatives.
• Recommend design changes and mitigation strategies to improve product safety.

Skills

Software Safety Engineering

Hazard Analysis – PHA, FTA, DFMEA, HAL

Product Reliability / Safety Engineering

Design for Reliability (DfR), DFSS, Lean Sigma

Implantable / Cardiac Medical Devices

Software Systems / Mobile Applications

Education

Bachelor’s or Master’s degree in Engineering, Science, Math, or related technical field

Job description

A leading medical device company is seeking a Senior Software Safety Engineer to enhance safety and reliability in cardiac rhythm management products. This role involves conducting safety assessments, risk analysis, and compliance with global standards. The ideal candidate will have a degree in a technical field and at least 4 years of experience in software safety within regulated environments. This position is fully onsite in Mounds View, Minnesota.