- Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.
- 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, Helix, Jama).
- 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
- Analyze design changes implemented after execution of verification and validation to determine regression testing required
- Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL , 1-2 and applicable collateral standards)
- Perform dry-running of new and updated Test Cases
- Perform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.)
- Perform and maintain product configuration management for assigned projects
- Ensure compliance with Insulet quality policies, procedures and practices
- Ensure compliance with all local, state and federal regulations, policies and procures
- Bachelors' Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, 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
- Strong technical judgement with extensive technical leadership skills
- Demonstrated capability of leading Verification & Validation Test Programs
- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
- Sound knowledge of engineering first principals
- 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
- Familiarity with System Level Testing of software based Medical Devices is a plus
- Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus
- 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 is a plus
- Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971
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System Engineer V&V(Hybrid) - Tijuana, México - Insulet Corporation
Descripción
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it
Job Title: Systems Engineer V&V
Department: Systems Engineering COE
FLSA Status: Exempt
Position Overview:
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. Education and work experience should encompass a wide array of engineering disciplines relevant to: mechanical testing, system testing, material testing, 3rd party (agency) testing, shelf life and aging testing, simulated use, and drug-device compatibility testing.
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:
Education and Experience:
Minimum Requirements:
Preferred Skills and Competencies:
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
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