Director, Medical Device Systems Engineering

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

Job summary

Intuvie Holdings LLC is seeking a Director of System Engineering in Natick, MA, to lead and contribute to the system-level development of infusion pump platforms, including new product development and on-market sustaining activities.

You will manage a team of engineers, drive architecture, risk analyses, human factors engineering, and V&V planning while ensuring compliance with QMS and regulatory requirements.

Qualifications

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

Responsibilities

• Grow and manage a team of 5 or more engineers.
• Oversee architecture specification, implementation, and performance accountability of new products in development.
• Lead NC and CAPA processes to resolve technical issues and improve products.
• Mentor engineers to develop skills and interface with cross-functional design teams.
• Establish and enforce system engineering practices for requirements, architecture, and design descriptions.

Skills

Team leadership

System engineering

Project management

Communication

Risk management

Agile/Waterfall

Regulatory awareness

Education

Bachelor’s degree in Biomedical/Systems/Mechanical/Electrical Engineering

Master’s degree

PhD degree

Tools

System engineering tools

Job description

Intuvie Holdings LLC is seeking a Director of System Engineering in Natick, MA, to lead and contribute to the system-level development of infusion pump platforms, including new product development and on-market sustaining activities.

You will manage a team of engineers, drive architecture, risk analyses, human factors engineering, and V&V planning while ensuring compliance with QMS and regulatory requirements.