Senior Systems Engineer, Verification and Validation

5 days ago

Acton, Massachusetts, United States Insulet Corporation Full time
Job Title:

Senior Systems Engineer, Verification and Validation

Job Summary:

Insulet Corporation is seeking a highly motivated and experienced Senior Systems Engineer to lead the Verification and Validation (V&V) activities for our medical device products. As a key member of our Systems Engineering team, you will be responsible for ensuring the quality and reliability of our products through rigorous testing and validation.

Key Responsibilities:
  • Manage all V&V activities and deliverables for new product development and sustaining products
  • Provide technical leadership for the System Design Verification team
  • Lead initiatives to advance processes and tools related to Design Verification activities
  • Develop, review, implement, and maintain test strategies, test protocols, test cases, test reports, and traceability matrices for system verification
  • Report defects found during testing and assist in root cause analysis
  • Drive the impact analysis and effort estimates
  • Collaborate with Systems Engineering to ensure that requirements are testable and appropriately leveled for verification with component-level test teams (HW/SW)
  • Coordinate with project managers, system engineers, and other technical leads to plan and execute project goals
  • Work closely with the System Automation Test team to optimize test coverage and test execution strategy
  • Define, track, and report KPIs for product verification and product quality
  • Mentor junior team members on topics such as sample size justification, statistical analysis, risk-based test coverage optimization
  • Manage and track product configurations, including hardware, software, and firmware version tracking, and determine the impact due to configuration changes for System Design Verification
  • Ensure compliance with regulatory standards and Insulet quality policies, procedures, and practices
Requirements:
  • Bachelor's Degree in Biomedical Engineering or a related field
  • Minimum of 5 years' experience testing medical devices in a multidisciplinary project team environment or advanced degree and 2+ years of experience
Preferred Skills and Competencies:
  • Strong technical judgment with extensive technical leadership skills
  • Demonstrated capability of leading System design verification for programs on an electromechanical device
  • Excellent Program Management Skills - PMP Certification a plus
  • Experience working in an Agile-based Software Development environment preferred
  • Experience guiding team/individuals to develop technical solutions to complex problems
  • Sound knowledge of engineering first principles
  • Strong Analytical and Problem-Solving Skills
  • Ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams
  • Good written and verbal communication skills
  • Familiarity with medical device System-Level Testing
  • Test Engineering training and/or certification is a plus
  • Experience working with requirements management tools, quality management systems, test case management tools, and defect management tools is preferred
  • Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls
  • Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971
Additional Information:

This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).

The US base salary range for this full-time position is $92,000 - $139,000. Our salary ranges are determined by role, level, and location.

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.

At Insulet Corporation, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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