- Professional
- Office in Plymouth
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)
Position Summary:
The Senior 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 system features (hardware and software) into marketable products with internal and external partners.
Key Responsibilities:
- Lead cross-functional teams through definition of new features/functions that are being incorporated into the product, ensuring the feature/function design meets the user needs and designed are prepared for timely incorporation into product development projects. This may include electrical, mechanical, software and/or system integration related definition tasks.
- Lead activities necessary to sufficiently de-risked new features/functionality and from a technical perspective for seamless integration into a formal development project. This may include leading prototyping, preclinical feasibility and other engineering feasibility studies and system integration impact assessments.
- Work closely with the R&D management and the cross-functional team to identify and translate clinical needs into engineering requirements for feature feasibility and development work.
- Manage development of appropriate requirements for new features/functions in close collaboration with cross-functional team, that ensure design will satisfy user, business and regulatory requirements.
- Manage discussions and plans for formal verification and validation testing for system, sub-system and software test strategies for new product features that include software and system level components and algorithms.
- Provide voice of the customer for features/functions as it is implemented and play a critical role in bridging technical and commercial perspectives.
- Complete planning, design and test documentation in accordance with HistoSonics’ design control system.
Qualifications and Skills:
- Bachelor’s degree in engineering required.
- 5+ years of product development engineering experience; systems engineering experience preferred.
- Medical device industry experience strongly preferred.
- Experience in complex systems design, engineering and product and test development. Experience with commercialized product support is a plus.
- Experience driving products through verification and validation, resulting in successful regulatory submissions (globally).
- Excellent communication skills and quality management systems experiences.
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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