R&D Project Manager New Indications

HistoSonics • Plymouth, MN

42d • Hybrid

About The Position

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 (Hybrid) Position Summary: The Project Manager provides leadership and direction to the projects and initiatives within HistoSonics' Project Portfolio. The key responsibilities of the Project Manager New Indications involve management of product development projects and other organizational projects and initiatives while closely adhering to HistoSonics' quality system and design controls. The Project Manager New Indications is also responsible for coordinating HistoSonics' clinical trial certification efforts for New Indications.

Requirements

• Bachelor's degree in engineering or science field preferred.
• 10+ years of product development experience in biosciences including medical device, pharmaceutical or similar field.
• Experience in Project Management, System Engineering, pre-clinical safety evaluation, clinical trial development, and first-in-man studies.
• Experience advancing products through early-stage clinical studies.
• Proven industry experience with leadership ability to engage and motivate teams and adapt to evolving business environments.
• Excellent written and verbal communication; able to simplify complex technology for diverse audiences and deliver high-level presentations.
• Strong interpersonal, facilitation, and relationship-building skills (internal and external).
• Track record of translating strategic plans into prioritized product, development, and operational objectives.
• Cross-functional experience with research, advanced technology, clinical, regulatory, and design assurance teams.
• Willingness to travel up to 20-25% (day trips and overnight).

Nice To Haves

• Background in HIFU, Focused Ultrasound, Diagnostic Ultrasound, or Ablative Technologies.

Responsibilities

• Plan and organize to support execution of projects within the HistoSonics R&D portfolio.
• Coordinate and complete project documentation and deliverables per company procedures.
• Manage project interdependencies across subsystems, including resource allocation to meet timelines.
• Collaborate with engineering leadership to align requirements and design implementation with schedules.
• Partner with engineering leadership and other project managers to ensure alignment on priorities and resources.
• Develop project plans using approved tools and quality system guidelines; conduct routine reviews and publish meeting minutes.
• Provide clear, consistent communication to project teams and senior leadership on status updates.
• Ensure compliance with the company's Quality Management System.
• Foster a positive, results-oriented environment, promoting teamwork and open communication.
• Maintain a clean, safe, and effective work environment.
• Stay informed on current and emerging industry trends.
• Manage third-party vendors to meet product and timeline requirements.
• Determine necessary resources to execute projects on schedule.
• Coordinate cross-functionally with Regulatory and Clinical teams to support trials and submissions.
• Oversee collection of preclinical safety data for regulatory submissions.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees