System Engineering Manager

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.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it

Job Title: Manager, Systems Engineering

Department: Systems Engineering LCE

FLSA Status: Exempt

Manager, Systems Engineering

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 post-market activities, including field investigations, CAPA execution, and obsolescence planning; they will drive continuous improvement to support product development and lifecycle management for in-market and near-market products.

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 root cause investigations, risk evaluations, and design change assessments ensuring seamless transition of information from the field to development and vice versa.
- Drive post-market initiatives, including field investigations, CAPAs, failure and risk analysis, health-hazard 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.
- Collaborate cross-functionally including but not limited to Customer Support, Product Support, R&D SW development, Product Management, Regulatory, Quality, DevOps.
- 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, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
- Minimum of 8 years of overall experience in systems engineering, lifecycle engineering, sustaining, 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
- Risk Analysis, Issue Management, Change management, and Root Cause Investigation Methods
- 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.
- 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

Physical Requirements:

- Must be able to sit or stand for 8 hours a day.