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HistoSonics, Inc. · 5 hours ago

Senior Software Risk Management Engineer

Twin Cities Area

Full-time

Hybrid

Senior Level, Lead/Staff

$125K/yr - $155K/yr

5+ years exp

HistoSonics, Inc. is a medical device company focused on advancing the science of histotripsy for non-invasive therapies. The Senior Software Risk Management Engineer will lead risk management activities for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), collaborating with cross-functional teams to ensure compliance with medical device design control standards.

Health CareMedicalMedical Device

No H1B

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

Qualification

ISO 14971FDA regulationsRisk management methodologiesCybersecurity requirementsHardware-software integrationSoftware development methodologiesAnalytical skillsCommunication skillsOrganizational skills

Required

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