Senior Safety Risk Engineer

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 or Ann Arbor, MI 

Position Summary:

The Senior Safety Risk Engineer will work within cross functional product development teams in support of HistoSonics’ new product development effort.  The key responsibility of the Senior Safety Risk Engineer is to carry out product safety risk management activities and generate risk management process deliverables adhering to the company’s quality management system.

Key Responsibilities:

• Develop and maintain risk management plans, hazard analyses, risk assessments, and risk management reports for new products from concept to commercial release
• Facilitate cross-functional risk analysis, risk assessment and risk reviews with key stakeholders including R&D, Design/Product Assurance, Clinical/Medical Affair, Manufacturing, and Regulatory teams.
• Provide guidance to all product development teams to perform risk analysis, define risk mitigation strategies & safety features, identify critical product specifications and safety characteristics of products.
• Ensure safety and risk control measures into product design requirements.
• Ensure definition of appropriate verification methods for implementation and effectiveness of risk control measures.
• Ensure and maintain traceability between risk control measures, design inputs & outputs, and verification/validation activities.
• Prepare risk management documents for regulatory submissions.
• Support design transfer to production by identifying essential product design outputs and inspection methods according to risk assessment results.
• Support post-market surveillance activities by assessing field data, evaluating the need for safety actions and updating risk management files accordingly.
• Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to team members in an open, balanced, and objective manner.
• Create/ maintain a clean, safe, and effective work environment.  

Position Qualifications and Skills:

• Bachelor’s degree in biomedical engineering or a closely related engineering/science discipline.
• 5 years of product development experience in medical devices.
• 2 years of risk management experience.
• Deep experience with ISO-14971 and risk management processes, tools and techniques (FMEA, FTA, UEA, PHA).
• Excellent written and verbal communication skills, with the ability to participate in engineering and medical/clinical discussions.
• Strong analytical, critical thinking, and problem-solving skills with an attention to detail.
• Familiarity with medical device standards and regulations is a plus (IEC 60601-x, IEC 62304, IEC 62366, ISO 13485).
• Travel up to 10% domestically.

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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