Manager, Systems Engineering

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title: Manager, Systems Engineering

Department: Systems Engineering LCE

FLSA Status: Exempt

Position Overview: 
The Manager, Systems Engineering will provide leadership through motivation, guidance, and open communication enabling the team’s growth and success. They will manage a team of systems engineers balancing technical expertise and leadership while ensuring technical risk reduction in engineering programs. Manager will oversee NPI and post-market activities, including CAPA execution, field investigations, and obsolescence planning; they will drive continuous improvement to support product development and lifecycle management.

Responsibilities: 

• Attract, develop and retain the best talent to ensure the highest standard of excellence in systems engineering resulting in the delivery of high-quality innovations to patients globally.

• Manage the development of hardware and software enabled systems, those that interact with human or machines, and functional activities relevant to achieving these goals. This includes driving functional excellence in identifying, breaking down and solving technical problems associated with design and development of system architectures, testing, product and other system engineering aspects.

• Champion best-in-class systems engineering methodologies, optimizing workflows and efficiency.

• Oversee change assessments, risk evaluations, and design transfer activities, ensuring seamless transitions from development to manufacturing and product launch.

• Drive post-market initiatives, including CAPA investigations, failure analysis, and obsolescence planning.

• Ensure traceability among design input, design output, verification/validation, and risk management artifacts to maintain a complete design history file within QMS compliance.

• Oversee integration, system verification, and reliability activities, and deliverables.

• Collaborate cross-functionally including but not limited to regulatory, quality, manufacturing, and engineering.

• Drive continuous improvement initiatives, refining systems engineering processes for better quality, compliance, and adherence to ALM and PLM frameworks.

Leadership & Interpersonal Skills

• Proven ability to motivate and mentor engineers in a highly regulated environment.

• Skilled in cross-functional collaboration, coordinating with leadership, technical experts, and external partners.

• Strong decision-making skills, balancing technical challenges with business objectives.

• Excellent communicator, able to engage stakeholders at all levels of an organization.

Education and Experience:  

• Bachelor of Science or higher in System Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Computer Science, or a related technical field.

• Minimum of 8 years of overall experience in systems engineering, lifecycle engineering, R&D, or related technical roles in medical devices or other regulated industries.

• At least 4 years of team leadership experience, which may include roles: managing direct reports, technical lead or project lead, in which candidate lead engineers.

• Demonstrated experience in:

• • Documentation requiring traceability and regulatory review

  • Authoring design inputs, V&V plans, protocols, and reports in compliance with ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820.30

  • Change management, risk analysis, and design transfer

  • CAPA execution, failure analysis, and post-market regulatory compliance

Preferred Skills and Competencies:

• Graduate Degree (MSc, PhD) in Engineering or Management.

• Conflict resolution expertise, ensuring coordination across teams.

• Excellent verbal and writing skills that enable communication to different levels.

• Organizational awareness and ability to garner support with a bias towards action.

• Proficiency in Lifecycle tools (e.g. Polarion ALM, Helix ALM).

• Six Sigma training or certification.

Physical Requirements:

• Six Sigma training or certification.