The Senior Systems V&V Engineer is senior member of the Mechanical, Materials and Systems Test 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, Advanced Technology & Engineering located at Insulet's Headquarters in Acton, MA.
* Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams. * 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, Helix, Jama). * Collaborate with 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 DV Test Team * Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL 60601-1, 1-2 and applicable collateral standards) * 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 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 * Perform verification testing following proscribed 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 procures
Education and Experience
* Bachelors' Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical 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 judgement with extensive technical leadership skills * Demonstrated capability of leading V&V Test Programs * Excellent Program Management Skills - PMP Certification a plus * Previous experience working in an Agile based Software Development environment strongly preferred. * Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process. * Experience guiding team/individuals to develop technical solutions to complex problems * 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 * Good written and verbal communication skills * Familiarity with System Level Testing of software based Medical Devices * Test Engineering training and/or certification is a plus * Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus * Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs adapt to business and market needs * 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 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971 *
Physical Requirements (if applicable):
* Not Applicable
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