Embedded Software Systems Engineer (Hybrid/Flexible)

Insulet Corporation-posted 3 months ago
$102,825 - $154,237/Yr
Full-time
Hybrid • Acton, MA
Miscellaneous Manufacturing
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The Embedded Software Systems Engineer will be an integral member of the R&D team directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet's design control processes including but not limited to writing and interpreting product requirements, risk analysis, software design and architecture and defect assessment. As part of a cross functional Agile team, you will work closely with the Product Owner, Software Engineering, Software QA and others to ensure the appropriate artifacts are provided timely for the Agile team to implement and deliver effectively. As such, you will gain deep knowledge of pump technology to effectively meet the responsibilities below.

  • Work with Software Engineers to drive the generation of Software Functional Requirements that meet the higher level Product Requirements as well as the intended goals defined in the product backlog items.
  • Lead cross-functional reviews and approval of such Software Functional Requirements.
  • Work with the Software Engineering team to document system hazards, failure modes, and risk mitigations.
  • Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.
  • Work very closely with Software Engineering, Product Owner, Software QA and other cross functional teams to ensure the appropriate deliverables are available timely to enable the Agile team effective execution.
  • Drive other activities such as defect triaging and others as needed.
  • Drive generation of appropriate deliverables in accordance to FDA and corporate SOPs.
  • Contribute to team goals by accomplishing related tasks as required.
  • BS in an Engineering (Biomedical, Electrical, Software) discipline preferred.
  • A minimum of three (3) years' experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment.
  • 2+ years of experience in working on technical design.
  • Domain expertise in one of more associated domains; preferably Software or Electrical Engineering.
  • Demonstrated understanding of Systems Engineering practices such as requirements management and risk analyses.
  • 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.
  • Ability to communicate at multiple levels of an organization.
  • Ability to organize and judge priorities in a dynamic environment.
  • Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
  • Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM).
  • Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
  • Experience with root cause analysis.
  • Experience with software tools and coding (C++).
  • Hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).
  • Travel is estimated at 10% but will flex depending on business needs.
  • US base salary range for this full-time position is $102,825.00 - $154,237.50.
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