Position Title: Director, System Engineering

Department: Product Development

Reports To: VP, R&D

FLSA: Exempt

GENERAL SUMMARY

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.

ESSENTIAL JOB FUNCTIONS

• 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 program team and ensure support and focus on program objectives.
• 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.

OTHER DUTIES AND RESPONSIBILITIES

• Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• 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' experience with system-level product design.
• 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.
• Innovative thinker who can make sound technological decisions while making necessary technological tradeoffs.
• Experience with specifying and implementing patient safety systems that are compliant with applicable standards and regulations.
• 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.
• Exceptional organization and communication skills.
• Ability to function in a fast-paced, growth industry and work environment.
• Experience with infusion pump development or other relevant fluidic systems preferred.