Principal Product Engineer - Connectivity

HISTOSONICS INC • Plymouth, MN

3h • 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 Principal Product Engineer will work with the HistoSonics Edison Connect product team and external technical teams in the translation of user needs to product feature feasibility, definition, development and testing of the Company’s globally regulated clinical systems and software. They will play an active leadership role in understanding connectivity-related product needs across various programs, initiatives, and key stakeholders cross-functionally, prioritizing and driving feasibility work of solution sets and leading a team to develop prototype software features into marketable products (internally and with external partners).

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related discipline
• 10 + years of experience in medical device product development
• 5+ years of medical device software development process experience
• Experience in complex systems design, engineering and product development
• Significant experience driving system level software features through verification and validation, resulting in successful regulatory product submissions
• Technical leadership (cross-functional) and partnership experience (with successful launches)
• Excellent communication skills and quality management systems experience

Nice To Haves

• Experience designing, driving, and leading the development of medical device connectivity-related and data analytics features
• Project management experience
• Experience working with a global team

Responsibilities

• Manages external software design partner feasibility and development work across various product/program needs, engaging in prioritization, technical direction, and definition of requirements and deliverables to meet project objectives.
• Works closely with clinical and medical teams to identify and define key data sets and analytics for collected device and treatment session data.
• Works closely with the R&D management team and the cross-functional team to translate connectivity-related user needs into engineering requirements for feature feasibility and development work.
• Brings voice of the customer and voice of the business for features/functions as it is implemented and plays a critical role in bridging technical and commercial perspectives.
• Leads the timely design definition of new product features developed internally and by external partners, inclusive of software and system level requirements and test strategy. This may include electrical, mechanical, software and/or system integration related tasks.
• Understands how new functions/features fit into the overall technical roadmap, in alignment with the Program Director.
• Leads efficient and effective project engineering and management, including leading and/or contributing to feasibility plan/testing/reports, engineering requirements and specifications, cost estimation/analysis where applicable, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
• Ensures that software and system design and development documentation is in accordance with Histosonics’ design control system (or external partner’s systems) and that all applicable project deliverables are completed (either internal or external).

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
• Number of Employees: 101-250 employees