System Engineer V&v

hace 7 meses

Tijuana, México Insulet Corporation A tiempo completo

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 itJob Profile Summary

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**:

- 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 Engineers 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
- 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:
Minimum Requirements:

- 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

Preferred Skills and Competencies:

- Strong technical judgement with extensive technical leadership skills
- Demonstrated capability of leading Verification & Validation 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

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