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Senior Systems Engineer – Software Focus

Medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform.
$109,800 - $164,700
Embedded
Senior Software Engineer
Remote
5+ years of experience
Healthcare · Enterprise SaaS

Description For Senior Systems Engineer – Software Focus

Insulet Corporation, a NASDAQ-listed medical device company, is seeking a Senior Systems Engineer with a software focus for their innovative medical device development team. This remote position, based in the San Diego area, involves leading software requirements development for wearable medical devices, cloud, and mobile applications. The role combines technical leadership in software systems engineering with medical device regulatory compliance.

The position offers an opportunity to work on life-changing technology in diabetes management, specifically the Omnipod Insulin Management System. You'll be responsible for driving software requirements development, managing technical reviews, and ensuring compliance with FDA guidelines. The role requires expertise in both software systems engineering and medical device development, making it ideal for someone who wants to impact healthcare technology.

Working in a hybrid/remote environment, you'll collaborate with cross-functional teams including software developers, systems engineers, product owners, and design quality experts. The company culture emphasizes innovation, customer focus, and work-life balance. With a competitive salary range of $109,800 - $164,700 and the flexibility of remote work, this position offers an excellent opportunity to contribute to meaningful medical technology development.

The ideal candidate will bring 5+ years of medical device development experience, strong systems engineering knowledge, and excellent stakeholder management skills. You'll be part of a company that's revolutionizing diabetes care through innovative technology, working on products that directly improve patients' lives.

Last updated 3 days ago

Responsibilities For Senior Systems Engineer – Software Focus

  • Lead and drive the development and analysis of software requirements
  • Lead technical reviews of software requirements with stakeholders
  • Create and maintain traceability matrices between requirements and design outputs
  • Generate requirement traces and reports for regulatory submissions
  • Manage software requirements and traceability in PLM and ALM tools
  • Review user stories with Product Owners
  • Review development artifacts to ensure implementation meets requirements
  • Review software test deliverables

Requirements For Senior Systems Engineer – Software Focus

  • Bachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science) or related degree
  • 5 years of experience in medical device products development
  • Skilled in requirements writing and analysis for software requirements
  • Understanding of Systems Engineering practices
  • Knowledge of application lifecycle management tools
  • Experience working in Agile development environments
  • Experience with Medical Device regulations
  • Strong communication and stakeholder management skills
  • Ability to work independently and manage multiple tasks

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