Senior Software Safety Enginee

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

Job Title: Senior Software Safety Engineer – Medical Device

Location: Mounds View, Minnesota (Fully Onsite)

Type: W2 Contract

Duration: 1 year

Job Summary:

We are seeking a Senior Software Safety Engineer with strong experience in medical device software safety, risk management, and reliability engineering to support cardiac rhythm management products. This role will work closely with cross-functional engineering, cybersecurity, human factors, regulatory, and quality teams to identify patient safety hazards, perform risk analysis, and ensure compliance with FDA and global medical device standards.

Key Skills Required

• 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

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.

Qualifications

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