Principal Engineer, New Indications

HISTOSONICS INC•Plymouth, MN

6h•Hybrid

About The Position

The Principal Engineer, New Indications, will be the Technical Lead 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 translating new concepts from laboratory prototypes into clinical evaluation and eventual commercialization.

Requirements

Bachelor’s degree in engineering.
8+ years of design, development, clinical evaluation and/or product transfer to production of medical devices; 5+ years with master’s degree.
Experience in complex systems design, engineering and product development (including product support during commercialization). Have a strong background in systems engineering.
Experience with early-stage clinical studies and clinical evaluation of new concepts. Have background and experience supporting first in man or human feasibility clinical studies.
Have background an experience in a start-up environment.
Project leadership (cross-functional) and partnership experience (with successful launches).
Significant experience driving products through verification and validation, resulting in successful regulatory submissions (global experience preferred).
Excellent communication skills and quality management systems experience.
Must be willing and able to travel up to approximately 25%.

Responsibilities

Works closely with Project Leads and the cross-functional team to translate clinical needs into engineering requirements.
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 project engineering, including leading and/or contributing to marketing specifications, engineering specifications, feasibility plan/testing/reports, cost estimation/analysis, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
Conduct 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.