Director, Systems Engineering

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Full Time Natick, MA, US

Salary Range: $ To $ Annually

Department: Product Development

Reports To: VP, R&D

FLSA :
Exempt

The Director, System Engineering leads and personally contributes to the system-level development behind our infusion pump platforms, including new product development and on-market sustaining activities. The scope of the department responsibilities includes product requirements, risk analyses, human factors/usability engineering, system-level architecture and design documentation, V&V test planning and execution, root cause analysis, CAPA/NC ownership, on-market change control and QMS updates for related procedures and processes.

This is a hands-on leadership role that brings a strong background in system engineering, medical device development and ability to mentor and lead a team of internal engineers and external contractors as needed. The position requires a solid understanding of system engineering principles while maintaining the flexibility to work within the existing process and toolsets without substantial reinvention. The role operates within our Quality Management System and partners closely with Software Engineering, Hardware Engineering, Project Management, Quality, and Regulatory to ensure system-level deliverables hold up our business, technical and regulatory requirements.

We are a small, privately held medical device company. We move quickly, avoid internal politics, and our leaders strive to make sound technical and process decisions decisively with data rather than by committee. Our size and scale afford autonomy, a flat and low-drama culture, and flexible working arrangement in support of a healthy work-life balance.

• Grow and manage a team of 5 or more junior to senior level engineers.
• Work closely with the Chief System Architect and Chief Engineer to oversee and contribute to the architecture specification, implementation and the performance accountability of new products in development.
• Facilitate and contribute to the resolution of technical issues and improvements of products in the field through NC and CAPA processes.
• Lead technical teams in a collaborative environment, completing program deliverables per target timelines, scope, and budget.
• Mentor younger engineers to develop the skills needed to resolve technical issues and interface with the broader cross-functional design team.
• Establish and enforce good system engineering practices for deliverables including product requirements, architecture and design descriptions, and system-level test methods and protocols.
• Serve as a primary technical interface with external product development contractors when required.
• Interface with the hardware and software design leads to ensure system architecture is translated into system design.
• Ensure system-level deliverables are consistent with our Quality Management System and support regulatory submissions.
• Facilitate progress with the right mix of Agile methods and Waterfall deliverables, resulting in an efficient and fast pace of progress.
• Work with Program Management to define and document program scope, constraints, and assumptions in detailed integrated program/project plans including schedule, resource needs, and budget.
• Generate and communicate metrics of progress for the engineering programs and projects.
• Establish and maintain a coherent perspective of program and technical risk and drive execution against risk mitigation plans as required to achieve program objectives and resolve technical issues.
• Hold team members accountable for areas of responsibility to the…