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Senior Software Safety Enginee
Job in
Mounds View, Ramsey County, Minnesota, USA
Listed on 2026-05-16
Listing for:
Grove Technical Resources, INC
Full Time
position Listed on 2026-05-16
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
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
- 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.
- 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.
Position Requirements
10+ Years
work experience
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