Senior Procedure Development Specialist

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: Remote 

Travel: up to 70%

Position Summary

The Sr. Procedure Development Specialist will collaborate with stakeholders to develop and implement innovative procedural solutions for current and future indications of the Company’s system(s). This role is pivotal in optimizing workflows, driving continuous improvement initiatives, and ensuring procedural standardization across various clinical applications. The Procedure Development Specialist, Sr. will work closely with cross-functional teams, including R&D, clinical research, regulatory, and commercial teams, to enhance procedural efficiency and support clinical adoption.

Position Expectations

• Lead, mentor, and develop Procedure Development Specialists and Clinical Education Specialists across the Company’s system(s) and indications.
• Participate in the planning, execution, and documentation of scientific and engineering experiments related to acoustical, electrical, and mechanical system components.
• Collaborate with R&D, regulatory affairs, and clinical teams to define requirements, and design outputs that align with customer and clinical needs.
• Act as a primary technical resource for the Company’s system(s) during clinical trials and feasibility studies.
• Develop and execute training programs for global and domestic clinical studies.
• Participate in the execution of formative, summative, and post-market assessments to inform feature development and procedural workflows.
• Work cross-functionally with education to support ongoing learning and development of the team.
• Work closely with the HistoSonics Education, Marketing, Sales and R&D teams to deliver world-class customer and employee training and education programs that enhance the value of the organization.
• Support and train internal education and clinical teams on new features, indications and continuous improvement projects (system, subsystem and software). 
• Implement continuous improvement initiatives to enhance workflow efficiency and ensure best practices across indications.

Qualifications:

• Bachelor’s degree in a relevant field required (e.g., Biomedical Engineering, Life Sciences, Nursing, or related discipline); advanced degree preferred
• 5+ years of clinical and educational experience with advanced imaging technologies (US, CT, MRI, IR). 
• General or abdominal sonography experience required. 
• Active ARDMS certification required.
• 5+ years of Direct clinical patient care experience in health care/medical industry required. 
• Proven ability to collect, synthesize, and communicate user feedback to internal teams to drive continuous product improvement.
• Demonstrated success in collaborating with cross-functional teams (R&D, marketing, clinical, regulatory, and engineering) to define new technology features and enhancements.
• Strong understanding of clinical workflows, hospital environments, and device integration in surgical or diagnostic settings.
• Excellent communication, presentation, and interpersonal skills, with the ability to engage effectively with clinicians, KOLs, and internal stakeholders.
• Ability to translate clinical needs into technical requirements and contribute to product development discussions.
• Familiarity with human factors engineering, usability studies, or post-market surveillance.
• Strong analytical mindset and ability to interpret user data, metrics, and clinical outcomes to inform development priorities.
• Demonstrated experience helping to launch or iterate new medical device technologies based on end-user feedback.
• Experience with clinical trial protocols, Good Clinical Practice (GCP), and medical device risk management is a plus.
• Travel up to 70% of the time both domestically and internationally.

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.