Systems Engineer, V&V (Hybrid- Acton, MA)
About The Position
The Systems Engineer V&V is a member of the Systems Engineering COE and a technical expert responsible for leading Systems Engineering activities related to verification and validation of Insulet’s products. The position will report to the Manager Systems Design Verification, Systems Engineering COE, Medical Devices R&D located at Insulet’s Headquarters in Acton, MA. Responsibilities: Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products. Develop detailed Verification and Validation Plans for assigned projects Develop detailed Verification schedules utilizing time based resourced management tools Experience with automation testing preferred Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Polarion, Helix, Jama). Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable Participate in the planning and execution of technical project work. Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes Conduct and encourage frequent formal and informal communication with team members to ensure full engagement and efficient operation. Analyze design changes implemented after execution of verification and validation to determine regression testing required Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification test team Develop new test cases and/or update existing test cases to match requirement updates and new understanding of system performance Perform dry-running of new and updated test cases Perform systemic reviews of test cases to ensure complete coverage of typical use and edge cases scenarios including happy-path, alternate path and negative path Perform and maintain product configuration management for assigned projects Perform verification testing using prescribed test cases for assigned projects. Other duties within the scope of the Position Overview as assigned Ensure compliance with Insulet quality policies, procedures and practices Ensure compliance with all local, state and federal regulations, policies and procedures
Requirements
- Bachelors’ Degree in Biomedical Engineering, Software Engineering, Systems Engineering, Computer Science, Electrical Engineering or a related field.
- Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience
Nice To Haves
- Strong technical judgement with extensive technical leadership skills
- Demonstrated capability of leading Verification & Validation Test Programs
- Familiarity with System Level Testing of software based Medical Devices
- Test Engineering training and/or certification is a plus
- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
- Strong Analytical and Problem-Solving Skills
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
- Experience in directing associates and leading small cross-functional teams
- Good written and verbal communication skills
- 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/procurement/manufacturing/regulatory and quality experts
- 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, ISO 14971 and ISO 9000
- Experience with automation testing preferred
Responsibilities
- Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products.
- Develop detailed Verification and Validation Plans for assigned projects
- Develop detailed Verification schedules utilizing time based resourced management tools
- Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Polarion, Helix, Jama).
- Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable
- Participate in the planning and execution of technical project work.
- Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes
- Conduct and encourage frequent formal and informal communication with team members to ensure full engagement and efficient operation.
- Analyze design changes implemented after execution of verification and validation to determine regression testing required
- Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification test team
- Develop new test cases and/or update existing test cases to match requirement updates and new understanding of system performance
- Perform dry-running of new and updated test cases
- Perform systemic reviews of test cases to ensure complete coverage of typical use and edge cases scenarios including happy-path, alternate path and negative path
- Perform and maintain product configuration management for assigned projects
- Perform verification testing using prescribed test cases for assigned projects.
- Ensure compliance with Insulet quality policies, procedures and practices
- Ensure compliance with all local, state and federal regulations, policies and procedures
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
