Director, Systems Engineering (Remote/Flexible)

Position Overview

Director, Systems Engineering leads teams in the requirement analysis, product definition, design, development and verification efforts of complex systems involving multiple subsystems (SW, HW), and a wide range of cutting-edge technologies and solution partners. This position is also responsible for sustaining existing on market products.

Responsibilities

• Recruit, develop and lead a team that will drive the definition, design, development, verification and regulatory approval of Insulet Products.
   

Individual and team responsibilities include:

• Gather needs from different stakeholders and translate them into system requirements.

• Maintain requirements across family products in collaboration with global stakeholders.

• Orchestrate data and system architecture efforts in collaboration with subsystem leads and solution partners.

• Lead risk management activities to plan, analyze and control design and use related risks.

• Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.

• Lead integration, subsystem, system verification and reliability activities creating plans, protocols and reports as necessary.

• Lead initiatives to identify, prioritize, define, and implement improvements to systems engineering processes to achieve best-in-class quality and reliability.

• Apply an expert understanding of systems to serve as a subject matter expert for the development team regarding behaviors, implementation trade-offs, satisfaction of customer needs, clinical applications, and the applicable technologies required to solve problems and deliver upon business objectives.

• Establish and maintain internal and external partnerships to leverage specialized engineering support and maintain cross functional alignment.

• Plan and execute the department strategy to meet goals and expectations; gathers information, frames problems, devises/executes plans, tracks progress and adjusts/measures success within scope of responsibility to improve development efforts as well as the organization.

Leadership/Interpersonal Skills & Behaviors

• Proven background in leading systems engineering teams focused on multiple and complex project design and development initiatives.

• Ability to motivate and lead a diverse staff to drive the execution of critical strategies and programs across a large organization.

• Ability to foster collaboration with cross-functional teams and other leaders to drive work to completion and resolve issues.

• Ability to form and develop interpersonal, professional and collaborative relationships; displays socially and professionally appropriate behavior.

Required Skills and Competencies

• Ability to accurately evaluate and assess complex processes; identify possible solutions and drive to resolution.

• Demonstrated skills in developing and introducing innovative FDA regulated medical devices (Class 1, 2 or 3).

• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).

• Familiarity with Human Factors and Usability Engineering standards and guidelines (AAMI/ANSI HE75, ISO/IEC 62366, UCM 259760).

• Experience supporting definition of regulatory strategies.

• Experience architecting and allocating requirements across multiple subsystems.

• Experience with a wide range of medical device risk analysis techniques and risk management deliverables (e.g. PHA, FTA, FMEA, HHEs, HRAs).

• Experience writing verification plans, protocols and reports according to medical device regulations.

Preferred Skills

• Experience writing Use cases, creating Storyboards and using Voice-of-Customer (VOC) techniques to facilitate requirements gathering efforts (Interviews, Surveys, KJ Analysis, CTQ, AHP, Kano Analysis and Critical Parameter management).

• Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is a plus.

• Experience managing globally distributed teams, consultants and contractors.

• Experience with advanced root cause analysis methods such as Statistical Analysis, Cause and Effect, A3, 5 Whys and 8Ds.

• Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.

• Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.

Education and Experience

• Bachelor’s degree in Engineering or other technical discipline. Master’s degree in engineering, technical discipline, or MBA, preferred.

• 10+ years of practicing engineering experience with progressive responsibility to develop the competence required to meet the skills and responsibilities of the position.

• 5+ years of functional management experience

Additional Information

• Travel is estimated at 10% but will flex depending on business need.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

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.