Sr Manager, System Safety and Compliance (Hybrid)

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 - $2