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
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.
Top Skills
What We Do
Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod® Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
