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Senior Systems Engineer
2 months ago
At Insulet Corporation, we are seeking a highly skilled Systems Engineer V&V to join our expanding team. As a key member of our Systems Engineering COE, you will be responsible for leading Systems Engineering activities related to verification and validation of our products.
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, 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.
- 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.
- Bachelor's 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 judgment 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.
- 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.
- 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.
The US base salary range for this full-time position is $71,843.00 - $107,764.25. 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.
At Insulet Corporation, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
