Director, 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 system-level development for infusion pump platforms, including new product development and on-market sustaining activities. This hands-on leadership role mentors engineers, partners with software/hardware, and ensures QMS/compliance for regulatory submissions.

You will drive architecture, risk management, and V&V efforts while balancing Agile and Waterfall processes to deliver on schedule and budget.

Qualifications

• 10+ years in engineering with relevant degree.
• 8+ years in system-level product design.
• 5+ years medical device development including 510(k) submission.
• Experience with infusion pump development or other fluidic systems.
• Knowledge of IEC 60601 and ISO 14971 risk management.
• Ability to mentor and lead cross-functional teams.

Responsibilities

• Grow and manage a team of 5+ engineers.
• Oversee architecture specification and development with the Chief System Architect.
• Lead NC/CAPA processes to resolve product issues.
• Drive program delivery on time, scope, and budget.
• Mentor engineers and collaborate with cross-functional teams.
• Establish and enforce system engineering deliverables and test methods.
• Interface with external contractors as needed.
• Ensure alignment with QMS and regulatory submissions.
• Balance Agile and Waterfall methods for efficient progress.
• Collaborate with PM to define program scope, schedule, and resources.
• Generate metrics and monitor progress across programs.
• Manage technical risk and mitigation plans.
• Hold team accountable for program objectives.
• Contribute to technical summaries and RFPs.
• Maintain positive team morale and progress.

Skills

System engineering

Leadership

Risk management

V&V testing

Cross-functional collaboration

Education

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

MS or PhD considered for advancement

Tools

System engineering tools

Job description

Intuvie is seeking a Director of System Engineering in Natick, MA to lead system-level development for infusion pump platforms, including new product development and on-market sustaining activities. This hands-on leadership role mentors engineers, partners with software/hardware, and ensures QMS/compliance for regulatory submissions.

You will drive architecture, risk management, and V&V efforts while balancing Agile and Waterfall processes to deliver on schedule and budget.