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 it!
Job Title: Systems Engineer V&V
Department: Systems Engineering COE
FLSA Status: Exempt
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: 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 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.
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 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
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information: The US base salary range for this full-time position is $86,100.00 - $129,450.00. 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.
