Senior Systems Engineer, V&V - Acton, Mass. (Hybrid)

Job Title: Senior Systems Engineer, V&V - Acton, Mass. (Hybrid)
Department: Systems Engineering COE
FLSA Status: Exempt

Position Overview: The Senior Systems V&V Engineer will be a technical expert responsible for leading Systems Engineering activities related to Verification and Validation of Insulet’s products.
The position will report to the Systems Design Verification Manager, located at Insulet’s Headquarters in Acton, MA.

Responsibilities:

• Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products.
• Provide technical leadership for System Design Verification team.
• Lead initiatives to advance processes and tools related to Design Verification activities according to System Engineering COE department objectives
•  Leads the development and execution of system integration, system verification and regression plan.
• 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 (Hardware/Software).
• Co-ordinate with project managers, system engineers and other technical leads to plan and execute project goals.
• Work closely with System Automation Test team to optimize test coverage and test execution strategy.
• Define, track and report KPIs for product verification and product quality
• Mentor to 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, 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.

Education and Experience:

• Bachelors’ Degree in Biomedical Engineering or an engineering related field preferred.
• Minimum of 5 years’ experience software testing, System Testing and/Product testing in a multidisciplinary project team environment or advanced degree and 2+ years of software testing, System Testing and/Product testing experience.
• Experience working in an Agile based Software Development environment. 
• Good written and verbal communication skills including cross functional communication experience.
• Experience working with a requirements management tool (Helix, Jama, and/or Polarion), quality management system, test case management tool and defect management tool.

Preferred Skills and Competencies:

• Strong technical judgement 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 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
• Familiarity with medical device System Level Testing
• Test Engineering training and/or certification is a plus
• 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

Physical Requirements (if applicable):

• Not Applicable

NOTE: 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). #LI-Hybrid 
 

Additional Information:

The US base salary range for this full-time position is $92,250.00 - $138,375.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. 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.