Principal Product Engineer

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)

Travel: Approximately 1 trip per quarter, primarily in the Midwest for 3-4 days, and a 1 week trip to Germany every year or two.

Position Summary:

The Principal Product Engineer will work with the HistoSonics 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 product needs across various programs and initiatives, 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). 

Key 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 the R&D management team and the cross-functional team to translate clinical needs into engineering requirements for feature feasibility and development work.
• Brings voice of the customer 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).

Required Qualifications and Skills:

• Bachelor’s degree in engineering plus 10 years related medical device product development work experience.
• Experience in complex systems design, engineering and product development inclusive of at least 5 years of medical device software development process experience. 
• 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 experiences
• Applicants must be authorized to work in the United States without the need for current or future sponsorship.
   

Preferred Qualifications and Skills:

• Advance image processing algorithm experience specifically with ultrasound and/or DICOM data sets
• Project management experience with external design partner

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.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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