Associate Development Engineer

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.

Location: Plymouth (hybrid)

Position Summary: (Why this role matters)

The Associate Development Engineer will work with the HistoSonics team in the design, engineering, development and testing of the Company's globally regulated clinical systems and serve as the engineering lead in the design and build of the system and/or sub-systems related to the Company's products, as well as launch support. They will play an active role in remediating existing design drawings and specifications to meet the growing business needs.

Key Responsibilities: (What you'll do)

• Develop an understanding of the HistoSonics system, understand the interactions between all the subsystems and understand how the Edison software interacts which each of the subsystems.
• Responsible for remediating existing design specifications by working through the input from cross-functional teams.
• Responsible for the timely design, engineering and development of the Company's product-related mechanical systems, subsystems and related devices. This includes electrical, mechanical, software and/or system integration related tasks.
• Duties are focused on efficient and effective development engineering, including: engineering specifications, R&D test development, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
• Conduct/support various engineering analytical evaluations related to the Company's product (e.g. tolerance, material selection, force, stress, thermal, ex vivo/preclinical testing, etc.).
• Participate in the engineering for manufacturability and transfer to manufacturing (e.g. assessment of molds/tools required, manufacturing equipment definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing.
• Ensures that design documentation is in accordance with Histosonics' design control system (or external partner's systems) and that all project deliverables are met.

Qualifications and Skills:

• Bachelor's degree in Mechanical, Biomedical or related engineering.
• 0-2 years related work experience, preferably in medical device.
• Experience with engineering software such as MatLab, Solidworks, MiniTab, etc.
• Experience with CAD is strongly preferred.
• Excellent written and verbal communication skills and excellent attention to detail.
• Experience working within a Quality Management system preferred.
• Ability to work somewhat independently in a collaborative, fast-paced environment.

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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