Director, Systems Engineering

Intuvie•Natick, MA

1d•$220,000 - $240,000

About The Position

The Director, System Engineering leads and contributes hands-on to system-level development for infusion pump platforms, including new product development and sustaining activities for products already on the market. The role oversees product requirements, risk analyses, human factors and usability engineering, system architecture and design documentation, verification and validation planning and execution, root cause analysis, CAPA and nonconformance ownership, on-market change control, and related Quality Management System updates. This is a hands-on leadership position requiring a strong background in systems engineering and medical device development. The Director mentors and leads internal engineers and external contractors as needed, working within existing processes and tools. The role partners closely with Software Engineering, Hardware Engineering, Project Management, Quality, and Regulatory to ensure system-level deliverables meet business, technical, quality, and regulatory requirements. The company describes itself as a small, privately held medical device company with a fast-moving, low-politics culture. It emphasizes autonomy, decisive technical and process decisions based on data, and flexible working arrangements intended to support work-life balance.

Requirements

10 or more years of experience with a bachelor's degree, 8 or more years with a master's degree, or 6 or more years with a PhD in Biomedical, Systems, Mechanical, or Electrical Engineering, or a related field.
At least 8 years of experience with system-level product design.
At least 8 years as a lead systems engineer, systems architect, or chief engineer on new product development.
At least 5 years of medical device development experience, including a successful 510(k) submission or higher.
Experience with systems involving electromechanical components, software, user interfaces, and disposable designs.
Excellent working knowledge of medical device development processes and systems engineering deliverables.
Ability to make sound technological decisions and appropriate technological tradeoffs.
Experience specifying and implementing patient safety systems compliant with applicable standards and regulations.
Mastery of relevant systems engineering tools.
Extensive working knowledge and application of IEC 60601 and related standards, as well as ISO 14971 for risk management.
Demonstrated ability to manage multiple engineering programs with shared resources.
Action-oriented, self-starting approach and ability to drive complex projects with minimal guidance or oversight.
Exceptional organizational and communication skills.
Ability to work in a fast-paced, growth-industry environment.

Nice To Haves

Experience with infusion pump development or other relevant fluidic systems.

Responsibilities

Grow and manage a team of five or more engineers, from junior to senior level.
Work with the Chief System Architect and Chief Engineer to oversee and contribute to architecture specifications, implementation, and performance accountability for new products in development.
Facilitate and contribute to resolving technical issues and improving products in the field through nonconformance and CAPA processes.
Lead technical teams collaboratively to complete program deliverables within target timelines, scope, and budget.
Mentor engineers in resolving technical issues and interfacing with the broader cross-functional design team.
Establish and enforce sound systems engineering practices for 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 needed.
Work with hardware and software design leads to ensure system architecture is translated into system design.
Ensure system-level deliverables are consistent with the Quality Management System and support regulatory submissions.
Facilitate progress using an appropriate mix of Agile methods and Waterfall deliverables.
Work with Program Management to define and document program scope, constraints, and assumptions in integrated plans covering schedules, resource needs, and budgets.
Generate and communicate progress metrics for engineering programs and projects.
Maintain a coherent view of program and technical risks and drive risk mitigation plans to achieve program objectives and resolve technical issues.
Hold team members accountable for their responsibilities to the program team and ensure focus on program objectives.
Contribute technical summaries and resource estimates during RFP generation for new projects.
Maintain and communicate a positive perspective on team progress.