The Senior Systems Lifecycle Engineer is a technical expert who leads and contributes to the definition, integration, and characterization of innovative product content. The successful candidate will drive system engineering activities within Life Cycle Engineering, including root cause investigations and in-depth analysis of product architecture, requirements and risks, providing effective solutions that adhere to stringent medical device regulations and quality standards. This role requires exceptional analytical, problem-solving, and communication skills to work effectively with multi-disciplinary teams. This position will report to the Manager of Systems Engineering within Systems Life Cycle Engineering.Key ResponsibilitiesSystems Design and Development<ul><li>Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.</li><li>Serves as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change.</li><li>Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems.</li><li>Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process. </li></ul>Risk Management and Compliance<ul><li>Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971.</li><li>Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601.</li><li>Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions.</li><li>Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies. </li></ul>Verification, Validation, and Testing<ul><li>Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation.</li><li>Coordinate testing to ensure compliance with all applicable safety and performance standards.</li><li>Analyze test data, interpret results, and formally document conclusions to verify that design outputs meet design inputs.</li></ul>Product Support and Sustaining Engineering<ul><li>Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities.</li><li>Analyze and address customer complaints and field issues through risk assessments and technical investigations.</li><li>Manage device and manufacturing process changes, including documentation updates and risk file maintenance. </li></ul>Leadership and Mentorship<ul><li>Guides and offers expertise with peers, providing guidance on systems engineering processes and tools.</li><li>Effectively communicate technical risks and proposed solutions to program level stakeholders. </li></ul>Qualifications<ul><li>Education: </li><li><ul><li>Bachelor of Science or higher in Engineering (e.g., Biomedical, Electrical, Mechanical, Systems) or related field. M.S. in engineering, related field or engineering management considered a plus.</li></ul></li></ul><ul><li>Experience: </li><li><ul><li>4+ years of experience working in the medical device industry/ highly regulated product development industry.</li><li>6+ years of experience working directly in a Systems Engineering discipline within product development.</li></ul></li></ul><ul><li>Technical Skills:</li><li><ul><li>Proficiency in system-level design, requirements management, and architectural development.</li><li>Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971).</li><li>Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization</li><li>Experience with requirements management software (e.g., Jama, Polarion, Doors) is required.</li><li>Experience with systems verification/validation, including test method development.</li></ul></li></ul><ul><li>Soft Skills:</li><li><ul><li>Strong analytical and problem-solving abilities.</li><li>Excellent written and verbal communication skills.</li><li>Demonstrated ability to collaborate effectively with cross-functional and global teams.</li><li>Strong organizational skills and attention to detail, particularly for regulatory documentation</li><li>Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs.</li></ul></li></ul>NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-HybridAdditional Information:The US base salary range for this full-time position is $99,825.00 - $149,737.50. 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.<div>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.<div><div><div><div><div><div><div>(<a href="https://www.eeoc.gov/poster" target="_blank">Know Your Rights</a>)</div></div></div></div></div></div></div></div>