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.