Principal, Analysis/Systems Engineering

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Full Time Natick, MA, US

Department: Product Development

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.

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.

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.

Contribute to technical summaries and resource estimates during RFP generation for new projects.

Maintain and project a positive attitude on the state of the union and the team’s progress.

10+ years of experience with a bachelor’s degree, 8+ years of experience with a master’s degree, or 6+ years of experience with a PhD degree in Biomedical, System, Mechanical, Electrical Engineering or a related field.

• Minimum of 8 years as a lead system engineer, system architect, or chief engineer on new product development.
• Minimum of 5 years medical device development experience, including successful 510k submission, or higher.
• Experience with systems involving electro-mechanical, software, user interface, and disposable designs.
• Excellent working knowledge of medical device development processes and system engineering deliverables.
• Mastery of relevant system engineering tools.
• Extensive working knowledge and application of IEC 60601 and related standards along with ISO 14971 for risk management.
• Demonstrated capability for managing multiple engineering programs with shared resources.
• Action-oriented self-starter who can drive complex projects with minimal guidance/oversight.