HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location: Plymouth, MN (Hybrid)

Travel Expectation: Approximately 25% to visit our other Midwest sites, Typically 1X per month for 2-3+ days.

Note: We are open to considering candidates at either the Senior or Principal level based on experience and qualifications. Compensation for this position will be commensurate with experience and level (Senior or Principal).

Position Summary:

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.

Key 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.

Qualifications and Skills:

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.

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.

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

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Senior Software Risk Management Engineer

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