R&D Project Manager

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 (On site)

R&D Project Manager

The Research and Development Project Manager proactively leads the planning, coordination, and execution of medical device development projects involving complex electromechanical systems integrated with software and firmware. This role is responsible for managing projects from concept through commercialization, ensuring cross-functional alignment, regulatory compliance, and timely delivery. The R&D Project Manager navigates a dynamic, cross-disciplinary environment with coordination and problem-solving proficiency.

Responsibilities

• Lead the execution of R&D projects, including new product development, product improvements, and technology feasibility efforts.
• Facilitate effective collaboration across cross-functional teams, including mechanical, electrical, software, and firmware engineering, as well as quality, regulatory, manufacturing, and marketing.
• Monitor progress, manage change control, and escalate risks and issues as needed to maintain project momentum.
• Serve as a central point of contact for internal and external stakeholders, providing regular project updates and status reports.

Qualifications

• Bachelor's degree in engineering, science or technical related field.
• 5-10+ years in medical device or regulated product development experience.
• 3+ years of proven track record of managing full product lifecycle projects, including complex electromechanical systems and software.
• Direct experience in product development environments with software and firmware integration.
• Experience working in matrixed organizations or cross-site/global teams.
• Exposure to manufacturing transfer and post-market support is a plus.
• Experience with FDA, CE marking, ISO 13485, and related documentation practices.
• Understands phase-gate or milestone-based product development.

Salary Range: $150,000-175,000.

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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