Sr. Product Assurance Engineer

HISTOSONICS•Plymouth, MN

4d•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. The Sr. Product Assurance Engineer will lead the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis. This role will work with Design Assurance on risk management updates and the transfer of design documentation into production and will collaborate closely with Manufacturing and Supply Chain to ensure that product meets requirements.

Requirements

Bachelor’s degree in engineering or related technical field
5+ years of progressive quality engineering experience in Supplier Quality, Quality Operations, or Manufacturing Quality, ideally within the medical device industry or another highly regulated manufacturing environment
Effective communicator who can work independently and collaboratively across all levels of the organization in a fast-paced, evolving environment
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Experience with risk management, nonconforming material, and complaint handling systems
Experience with practical application of statistics for product inspection and testing
Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971

Responsibilities

Leads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies
Supports supplier evaluation, auditing, and performance monitoring
Supports development of in-process and final product testing
Supports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test protocols
Leads process FMEA (PFMEA) development and ongoing updates
Collaborates with design assurance and manufacturing engineering to ensure that procedures, practices, and documentation comply with applicable standards and regulations
Supports the transfer of specifications and processes to production during the design transfer phase
Supports equipment control and process validations
Reviews Device History Records (DHR) and completes product release
Leads nonconforming material review and documentation
Uses knowledge of statistics to support inspection, testing, and process validation activities
Performs product complaint analysis including associated risk management file reviews and updates
Acts as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis
Develops, modifies, and maintains quality system procedures, work instructions, and forms
Support internal and external audit activities as needed
Lead CAPA investigations, action planning, and follow-up for assigned CAPAs
Maintains a safe and clean work environment
Other duties as assigned