Senior Product Development Engineer - Sustaining

HISTOSONICS INC•Plymouth, MN

6h•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. The Senior Development Engineer will work with the HistoSonics team to develop and implement design changes to Company’s globally regulated clinical systems in response to feedback received from customers, complaint data, supplier feedback and sourcing constraints. This is a hands-on role hands-on role for someone that leads technical root cause investigations and system characterization efforts for our advanced medical device capital equipment. The Senior Development Engineer will work cross-functionally across engineering, quality, regulatory and manufacturing to resolve challenging system and sub-system level issues and improve product performance, reliability, and compliance.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related discipline.
5+ years of product development experience in medical device, ideally with capital equipment or complex systems integration.
Experience and proficiency with SolidWorks or equivalent CAD program
Experience in complex systems design, engineering, and product development (including product support during commercialization).
Experience driving products through verification and validation, resulting in successful regulatory submissions (globally)
Excellent communication skills—able to drive alignment, clearly document findings, and present to diverse technical and non-technical stakeholders.
Prior involvement in field issue investigations or post-market support for medical equipment preferred.

Responsibilities

Develop a deep understanding of the HistoSonics system, understand the interactions between all the subsystems and understand how the Edison software interacts which each of the subsystems.
Work with cross-functional teams (Operations, Regulatory, Quality, Marketing, Supply Chain, field service, etc.) to scope and manage development projects related to commercialized product changes and updates. This includes running project meetings, assigning tasks to cross-functional team members, tracking deliverables, and driving projects to closure.
Lead design-related efforts for projects related to cleared/approved commercialized products. This includes identifying and updating impacted product requirements, assessing related risks, writing test protocols, executing design verification testing, analyzing data, writing reports, and drafting change orders to document and rationalize the impact to commercialized product(s).
Assist the quality engineering team with field reported issues. This may include evaluating products in the field and developing a plan to resolve any issues experienced by the customer. This will require working with the SMEs in R&D.
Lead structured root cause investigations for system-level issues across mechanical, electrical, firmware, and software domains.
Document findings in clear, structured formats suitable for design history files (DHF), CAPA, nonconformance investigations, and regulatory audits. Ensure the design documentation is in accordance with HistoSonics’ design control system (or external partner systems).
Provide technical leadership and mentorship during integration phases of product development and V&V.
Identify design improvements and risk mitigations based on investigation outcomes.
Maintain awareness of relevant medical device standards (e.g., IEC 60601, ISO 14971) and design control requirements.
Develop field service documentation to record the repair strategy and describe how to repair the device.