Senior Software Risk Management Engineer

HistoSonics • Plymouth, MN

64d • Hybrid

About The Position

The Senior Software Risk Management Engineer involves leading risk management activities for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This role supports software development from concept through commercialization and serves as a core team member of the software development team.

Requirements

• 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 the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 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 on 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.

Responsibilities

• Responsible for evaluating and updating 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.
• The application of ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control standards.
• Anticipates technical challenges and risk scenarios and prepares, manages, and implements mitigation strategies to ensure optimal results
• Support Regulatory Affairs with creating 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 & 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees