Job Description
Position Overview:
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: software testing, mechanical testing, system testing, 3rd party (agency) testing, shelf life and aging testing and simulated use 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 sustaining products.
- Develop detailed Verification and Validation Plans for assigned projects
- Develop detailed Verification schedules utilizing time based resource 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-runs 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 procedures
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
- 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
Physical Requirements (if applicable):
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). #LI-Hybrid
Additional Information:
Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $75,375.00 - $113,062.50This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:• Medical, dental, and vision insurance• 401(k) with company match• Paid time off (PTO)• And additional employee wellness programsApplication Details:This job posting will remain open until the position is filled.To apply, please visit the Insulet Careers site and submit your application online.Actual pay depends on skills, experience, and education.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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!
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.
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Job Tags
Full time, Work experience placement, Work at office, Local area, Remote work,