Senior Software Systems Engineer

3 days ago


San Diego, California, United States Insulet Corporation Full time

At Insulet Corporation, we are seeking a highly skilled Senior Software Systems Engineer to join our team of innovative professionals.

Job Summary:

We are looking for a motivated and experienced Senior Software Systems Engineer to lead and drive the development and analysis of software requirements supporting the software development life cycle of Insulet's innovation pipeline of wearable medical devices, including cloud and mobile applications.

Responsibilities:
  1. Software Requirements Development: Responsible for the development of software requirements by analyzing user needs and product requirements.
  2. Technical Leadership: Lead and drive the technical reviews of software requirements with the required stakeholders from various cross-functional teams.
  3. Requirement Management: Create and maintain traceability matrices between requirements, design verification outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines.
  4. Reporting and Compliance: Generate requirement traces and reports as needed for regulatory submissions.
  5. Software Management: Manage software requirements and traceability in Insulet's PLM and ALM tools, including version controlling of the documents.
  6. Collaboration and Communication: Review and consult with Product Owners on user stories that incorporate software requirements, ensuring sufficient detail is provided to guide the Agile development teams.
  7. Quality Assurance: Review downstream engineering teams' development artifacts such as design/architecture documents, design failure mode analysis to ensure implementation meets the specified requirements.
  8. Test Planning: Review software test deliverables such as test strategy and test cases to ensure alignment with the requirements.
Requirements:
  1. Education: Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree is required.
  2. Experience: A minimum of five (5) years of experience working on the technical development of medical device products.
Preferred Qualifications:
  • Formal training in established Systems Engineering concepts.
  • Any Formal training or requirement development related certification.
  • Knowledge of diabetes management products.
  • Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
  • Experience with change orders within a Product Lifecycle Management (PLM) tool.
  • Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.


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