Product Assurance Manager

HISTOSONICS INC • Plymouth, MN

19d • Onsite

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Position Summary:

The Product Assurance Manager leads a team of Product Assurance engineers responsible for commercial production support, including product inspection, release, nonconforming material handling, and complaint analysis. This role serves as a key liaison between Product Assurance, Design Assurance, Manufacturing, and Supply Chain to ensure that products consistently meet design specifications, regulatory requirements, and customer expectations. Coordinates all the assurance related activities that include but are not limited to supplier management, inspection/testing, product performance and projects that support the achievement of departmental and company objectives. The Manager fosters a culture of quality and continuous improvement while developing and mentoring engineering talent within the department.

Requirements

• Bachelor’s degree in engineering, Computer Science, Mathematics, or related field (MBA preferred).
• 7+ years of Quality experience in medical device or related industry.
• 4+ years of leadership experience managing or mentoring engineering teams.
• Strong communication skills with the ability to influence across all levels.
• Proven ability to manage multiple priorities in a fast-paced environment.
• Working knowledge of risk management, nonconforming material, and complaint handling processes.
• Experience applying statistical methods to inspection, testing, and process validation.
• Familiarity with FDA regulations, ISO 13485, EU MDR, and ISO 14971.
• Experience with FMEA, process validation, and quality tools (SPC, DOE, etc.).
• Proficiency in Microsoft Office and MRP/ERP systems.

Responsibilities

• Manages, mentors, and develops a team of Product Assurance Engineers, including hiring, performance management, and professional development planning.
• Oversee and coordinates product assurance activities including inspection strategy, product release, nonconforming material review, and complaint analysis.
• Ensures the development, implementation, and ongoing maintenance of process FMEAs (PFMEAs) and associated risk management activities.
• Partners with Design Assurance to support design transfer activities, ensuring specifications, procedures, and documentation are accurately transitioned into production.
• Collaborates with Manufacturing Engineering, Supply Chain, and Operations to deploy and maintain effective process controls, in-process testing, and final product inspection strategies.
• Supports supplier qualification, auditing, and ongoing performance monitoring in coordination with Supply Chain.
• Oversee equipment control and process validation activities, ensuring appropriate statistical methods are applied.
• Manages the reviews of Device History Records (DHRs) and ensures timely, compliant product release.
• Supports CAPA investigations, action planning, and follow-up for assigned corrective and preventive actions.
• Drives continuous improvement initiatives to reduce nonconformances, complaints, and overall product quality risks.
• Develops, reviews, and maintains quality system procedures, work instructions, and forms to ensure compliance with applicable standards and regulations.
• Establishes and monitors quality metrics and KPIs to assess team performance and product quality trends, reports findings to the Director of Product Assurance.
• Acts as Subject Matter Expert (SME) during internal and external audits and regulatory inspections for product inspection, risk, nonconforming material, and complaint handling, etc.
• Supports the Director of Product Assurance in departmental planning, resource allocation, and budget management.
• Maintains a safe and clean work environment and enforces compliance with applicable safety standards.
• Other duties as assigned by the Director of Product Assurance.

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: Manager
• Number of Employees: 101-250 employees