Senior Software Risk Management Engineer

Senior Software Risk Management Engineer

Histo Sonics, Inc. is a medical device company founded in 2009 that develops a non‑invasive sonic beam therapy platform using histotripsy to treat liver tumors.

Location
:
Plymouth, MN (Hybrid)
Travel Expectation
:
Approximately 25% travel; typically 1X per month for 2‑3+ days.

Seniority Level
:
Senior or Principal (based on experience and qualifications)
Compensation
:
Base pay $/yr – $/yr (commensurate with level)

The Senior Software Risk Management Engineer leads risk management activities for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting software development from concept through commercialization and serving as a core team member of the software development team.

• Evaluate and update risk documentation in response to product design changes, new software features, or post‑market feedback.
• Collaborate cross‑functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use.
• Apply ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control standards.
• Anticipate technical challenges and risk scenarios and prepare, manage, and implement mitigation strategies.
• Support Regulatory Affairs with submissions and responding to submission questions.
• Support internal and external audits by providing risk file documentation and responding to auditor inquiries.
• Track and manage risk file updates using document control systems.
• Support continuous improvement in design control and risk management quality processes and methodologies.
• Provide guidance in software change control for defect tracking and resolution.
• Participate in risk‑related training and continuous improvement initiatives.

• Bachelor’s degree in Computer Science, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related discipline.
• Minimum 5+ years of experience in regulated industry or medical device development.
• Extensive knowledge of FDA medical device quality system regulations and international quality system standards/regulations (ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820, MDSAP, EU MDR).
• Experience with risk management methodologies including FMEA, Fault Tree Analysis, and Hazard Analysis.
• Strong working knowledge of cybersecurity requirements.
• Expertise in hardware‑software integration for medical device.
• Strong understanding of software development methodologies.
• Demonstrated understanding of risk‑based approaches to processes and decisions.
• Excellent written and verbal communication skills.
• Detail‑oriented with strong organizational and analytical skills.

We offer a comprehensive benefits package for full‑time employees, including health, dental, and vision insurance; life, short‑term and long‑term disability insurance; a 401(k); paid time off; and more.

We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Histo Sonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.