Sr Manager, System Safety and Compliance (Hybrid) at Insulet in Acton, Massachusetts

Job Description:

The Senior Manager, System Compliance and Safety will manage a team of systems engineers and compliance engineers responsible for evolution of our processes governing product safety and for ensuring compliance of our system to global standards. This position will coordinate with program teams across the portfolio to plan and execute compliance activities. This position will also coordinate the development and execution of quality plans impacting our product safety process. This position will also contribute directly to product development as a technical leader in compliance, safety, and risk and lead by example in the professional responsibilities of Systems Engineering. Together with the broader team, this role will directly contribute to the development and delivery of solutions that meet or exceed customers' expectations with on-time delivery of high quality and excellent value. The position will report to the VP of Systems Engineering, within the Systems Engineering Center of Excellence.

Responsibilities:

• Develop, lead, and enable a team of Compliance Engineers responsible for the compliance testing and evaluation of our product against global regulatory standards including but not limited to IEC 62304, IEC 60601-1, and IEC 60601-1-2.


• Coordinate compliance activities with team across a broad and dynamic program portfolio to support the execution of the portfolio plan on time and with all testing complete to adhere to global standards and ensure access to targeted global market.


• Oversee the contracts and SoW's with third party test houses to support compliance activities.


• Provide management review of new and updated international standards for impact to Insulet test strategy and processes.


• Provide strategic vision for evolution of Insulet safety processes to improve efficiency, reflect the performance of our system in the field, and ensure the safety of our product for our users.


• Develop quality plans to implement changes to our safety processes and support a team of System Engineers in the execution of those plans.


• Support the safety evaluation of issues escalated from user complaints.


• Elaborate and allocate strategic departmental objectives to align the team with broader R&D and Insulet objectives and to challenge and grow team capability while delivering on organizational priorities.


• Engage with peer leaders across the organization to develop a coordinated, cross-functional approach the safety, quality, and efficacy of the Insulet's products.

Minimum Qualifications:

• B.S. or higher degree in an Engineering or related field.


• Minimum Eight (8) years of experience in the field with Four (4) years of experience working in medical devices / highly regulated product development industry.


• Demonstrated expertise in global standards and safety related processes.


• Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization.


• 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.

Preferred Skills and Competencies:

• M.S. in engineering, related field or engineering management considered a plus.


• Team Leadership: Demonstrated experience leading and mentoring individual or small teams of engineers.


• Time and schedule management: Experience balancing individual time and priorities in a dynamic multi-program environment.


• Collaboration: Experience working closely across departmental boundaries to achieve a coordinated, cross-functional strategies for product development.


• Process Innovation: Demonstrated ability to evolve processes to incorporate best-in-class agile methodologies to improve efficiency and quality while maintaining full compliance.


• Communication: Strong written and verbal communicator, ability to communicate with both team members and stakeholders throughout project life cycles.


• Conflict: Strong technical judgement in solving/resolving conflicts.

Physical Requirements (if applicable):

• Some travel expected as necessary to support cross site collaboration expected to be less than 10%.


• NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid

Additional Information:
The US base salary range for this full-time position is $159,000.00 - $238,500.00. 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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