Senior Systems Engineer (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:
The Senior Systems Engineer will be a technical lead in the design and development of Insulet’s products. This position entails leading systems engineering activities within new product development projects. Education and work experience should encompass a vast array of engineering disciplines to include, software, communications, electrical, mechanical, and materials.

The position will report to the Systems COE Leader, New Product Development and Commercialization, located at Insulet’s Headquarters in Massachusetts.
Responsibilities: Include
• Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
• Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
• Contribute to system development by defining system and subsystem architectures
• Identify and document system hazards, failure modes, and risk mitigations
• Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
• Serve as technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
• 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.
• Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
 
Education and Experience:
Minimum Requirements:
• Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required,.
• A minimum of 8 years’ experience working as a Systems Engineer or with systems engineering Responsibilities: in a multidisciplinary project team environment.
• 2+ years of experience in leading a cross-functional development team.
• Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering
• Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
• Experience writing verification plans, protocols and reports in a regulated industry.
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• 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.
Preferred Skills and Competencies:
• Master of Science degree is desired; System Engineering training and/or certification is a plus
• Experience or formal training in established Systems Engineering concepts.
• 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.

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 

Additional Information:

The US base salary range for this full-time position is $101,970.00 - $152,955.00. 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.