Senior R&D Engineer – System Safety

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 

Position Summary:

The Senior R&D Engineer – System Safety will work within cross functional product development teams in support of HistoSonics’ new product development effort.  The key responsibility of this role 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 identification of characteristics related to safety in new features, new products or new indications for existing products.
• Facilitate cross-functional hazard identification and analysis, 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 incorporation of safety aspects and risk control measures into product design requirements.
• Ensure the 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.
• Collaborate with Clinical Affairs by facilitating and producing safety risk management inputs in the development of clinical studies.
• 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 new product risk management experience
• Deep experience with ISO-14971 and risk management processes, tools and techniques (hazard analysis, 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 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 15% domestically.

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).

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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