Principal Systems Engineer

HISTOSONICS INC • Plymouth, MN

1d • Hybrid

About The Position

The Principal Systems 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. This role will lead seamless integration of hardware and software subcomponents and maintaining system architecture. The ideal candidate will bring deep expertise in embedded systems, medical device development, and cross-functional collaboration.

Requirements

• Bachelor’s degree in engineering plus 8+ years related medical industry work experience.
• Experience in complex systems design, engineering, and product development (including product support during commercialization).
• Experience driving products through development, verification and validation, resulting in successful regulatory submissions (globally)
• Excellent communication skills and quality management systems experiences

Responsibilities

• Work within the product development lifecycle with a focus on requirements, traceability, and risk management.
• Work with SMEs in R&D on difficult root cause analysis for bugs discovered during testing or complaints coming from the field.
• Work with cross-functional teams (Product Development, Software Engineering, Operations, Regulatory, Quality, Marketing) to scope projects related to commercialized product changes and updates.
• Manage projects related to commercialized product changes and updates. This includes running project meetings, assigning tasks to team members, tracking deliverables, and driving projects to closure.
• Lead design-related efforts for projects related to cleared/approved commercialized products. This includes identifying and updating impacted product requirements, assessing related risk, writing test protocols, executing testing, analyzing data, writing reports, and drafting change orders to document and rationalize the impact to commercialized product(s).
• Assist the engineering team with field reported issues. This may include evaluating product in the field and developing a plan to resolve any issues experienced by the customer. This will require working with the SMEs in R&D.
• Work with key stakeholders (cross-functional leadership) to determine appropriate priority of work related to commercialized product and product support, continuation, and service-related activities.
• Ensure that design documentation is in accordance with HistoSonics’ design control system (or external partner’s systems) and that all project deliverables are met.
• Work with cross-functional team to support, document, and track complaint handling.
• Work with the development team to develop field service training related technical materials that can be used to train future field service engineers who will provide support for the product.
• Champion improvements in systems engineering processes and tools.

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: Principal
• Number of Employees: 101-250 employees