Principal Systems Engineer

4 days ago


Boston, Massachusetts, United States Warwick consulting Full time
Job Title: Principal Systems Engineer

We are seeking a highly skilled Principal Systems Engineer to join our team at Warwick Consulting. As a key member of our team, you will be responsible for collaborating with clients to align user needs and business objectives with customer and stakeholder requirements.

Key Responsibilities:
  • Translate user and stakeholder requirements into well-defined customer and stakeholder requirements.
  • Analyze use cases and document the product lifecycle.
  • Develop detailed Software Requirement Specifications (SRS) and ensure implementation and test coverage.
  • Manage the Design History File (DHF) to ensure compliance with industry standards.
  • Apply a strong working knowledge of the design control process throughout the software development lifecycle.
  • Collaborate or lead efforts to develop and execute verification and validation activities.
  • Drive product development through all life cycle stages, ensuring compliance and functionality.
  • Leverage a strong understanding of IEC 62304 and other relevant ISO standards to guide development.
  • Understand clinical validation requirements, including usability and human factors testing.
  • Utilize requirements management tools and V&V activities.
  • Cross-functional collaboration to align on deliverables and objectives.
  • Support, track, and manage product issues and changes throughout the lifecycle.
  • Familiarity with continuous integration and delivery practices.
Qualifications:
  • Proven experience in systems engineering, particularly in medical device software development.
  • Strong understanding of the software development life cycle (SDLC), product development processes, and design controls.
  • Hands-on experience with requirements management tools and V&V activities.
  • Knowledge of IEC 62304, ISO standards, and regulatory compliance within the medical device sector.
  • Excellent communication and presentation skills.
  • Minimum 5 years of experience required for this role.


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