Position Overview:  The Embedded Software Systems Engineer will be an integral member of the R&amp;D team directly supporting the product development phases of Insulet’s innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet’s design control processes including but not limited to writing and interpreting product requirements, risk analysis, software design and architecture and defect assessment.  As part of a cross functional Agile team, you will work closely with the Product Owner, Software Engineering, Software QA and others to ensure the appropriate artifacts are provided timely for the Agile team to implement and deliver effectively. As such, you will gain deep knowledge of pump technology to effectively meet the responsibilities below.  Responsibilities:  <ul><li>Work with Software Engineers to drive the generation of Software Functional Requirements that meet the higher level Product Requirements as well as the intended goals defined in the product backlog items.  </li><li>Lead cross-functional reviews and approval of such Software Functional Requirements. </li><li>Work with the Software Engineering team to document system hazards, failure modes, and risk mitigations. </li><li>Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines. </li><li>Work very closely with Software Engineering, Product Owner, Software QA and other cross functional teams to ensure the appropriate deliverables are available timely to enable the Agile team effective execution. </li><li>Drive other activities such as defect triaging and others as needed </li><li>Drive generation of appropriate deliverables in accordance to FDA and corporate SOPs  </li><li>Contribute to team goals by accomplishing related tasks as required. </li></ul> Education and Experience: <ul><li>BS in an Engineering (Biomedical, Electrical, Software) discipline preferred</li><li>A minimum of three (3) years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment. </li><li>2+ years of experience in working on technical design </li><li>Domain expertise in one of more associated domains; preferably Software or Electrical Engineering </li><li>Demonstrated understanding of Systems Engineering practices such as requirements management and risk analyses. </li><li>Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts. </li><li>Ability to communicate at multiple levels of an organization </li><li>Ability to organize and judge priorities in a dynamic environment </li></ul> Preferred Skills and Competencies: <ul><li>Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). </li><li>Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM) </li><li>Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market. </li><li>Experience with root cause analysis </li><li>Experience with software tools and coding (C++) </li></ul>Additional Information<ul><li>NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid </li></ul><ul><li>Travel is estimated at 10% but will flex depending on business needs.</li></ul>Additional Information:The US base salary range for this full-time position is $102,825.00 - $154,237.50. 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>