Insulet Corporation · 4 days ago
Systems Engineer, V&V - Medical Devices
Acton, MA
Full-time
Hybrid
Mid, Senior Level
$75K/yr - $113K/yr
3+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Systems Engineer V&V will lead Systems Engineering activities related to the verification and validation of products, ensuring compliance with standards and developing detailed plans for testing new and existing medical devices.
Health CareMedicalMedical Device
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
Qualification
Required
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
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
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase