Director of Medical Systems Engineering

Intuvie; Natick (MA); On-site; USD 220,000 - 240,000; Full time

Job summary

Intuvie is seeking a Director of System Engineering in Natick, MA to lead the system-level development behind infusion pump platforms. You will oversee requirements, risk analyses, usability engineering, and V&V planning, while mentoring a team of engineers and coordinating with contractors.

The role requires a strong background in medical device development, regulatory submissions, and the ability to balance Agile and Waterfall processes to deliver high-quality system-level deliverables.

Qualifications

• Bachelor’s, Master’s, or PhD in a relevant engineering field.
• 8+ years in system-level product design.
• 8+ years as lead system engineer/architect on new product development.
• 5+ years medical device development including 510(k) submissions.
• Experience with electro-mechanical, software, UI, and disposable designs.

Responsibilities

• Grow and manage a team of 5+ engineers.
• Oversee architecture specification and product development.
• Lead NC/CAPA-driven technical issue resolution.
• Guide program delivery to meet timelines, scope, and budget.
• Mentor engineers to resolve issues and interface with cross-functional teams.
• Enforce system engineering practices for requirements, architecture, and test methods.
• Interface with external contractors when required.
• Ensure design translates to system architecture and regulatory deliverables.
• Support Agile and Waterfall processes to drive progress.
• Document program scope, constraints, and budgets with PM.
• Generate metrics and manage technical risk.

Skills

System engineering

Leadership

Mentoring

Agile/Waterfall

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Biomedical, System, Mechanical, or Electrical Engineering

Master's degree in relevant field

PhD in relevant field

Tools

IEC 60601 compliance

ISO 14971 risk management

System engineering tools

Job description

Intuvie is seeking a Director of System Engineering in Natick, MA to lead the system-level development behind infusion pump platforms. You will oversee requirements, risk analyses, usability engineering, and V&V planning, while mentoring a team of engineers and coordinating with contractors.

The role requires a strong background in medical device development, regulatory submissions, and the ability to balance Agile and Waterfall processes to deliver high-quality system-level deliverables.