Job Title: Manager, Systems Engineering
Department: Lifecycle 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 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 led engineers.Demonstrated experience in:Documentation requiring traceability and regulatory reviewAuthoring design inputs, V&V plans, protocols, and reports in compliance with ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820.30Change management, risk analysis, and design transferCAPA execution, failure analysis, and post-market regulatory compliance
Preferred Skills and Competencies:
Physical Requirements:
Must be able to sit or stand for 8 hours a day.NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $138,000.00 - $207,000.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.Insulet Corporation (NASDAQ: PODD), 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 tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. 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. For more information, please visit insulet.com and omnipod.com.
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!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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