Insulet Corporation Principal Systems Test Engineer in Billerica, Massachusetts
The Principal Systems Test Engineer is senior 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 vast array of engineering disciplines relevant to: mechanical testing, system testing, material testing, shelf life and aging testing, simulated use, and drug-device compatibility testing.
The position will report to the Systems COE Leader, Advanced Technology & Engineering located at Insulet’s Headquarters in Billerica, MA.
Establish and maintain standards and procedures governing test method and test tool development, validation, and release
Remain abreast of standards and regulatory requirements affecting Insulet’s systems and develop and execute plans for Insulet to have available compliant testing to demonstrate conformance. Specific areas of focus include physical integrity testing, shelf life testing and drug-device compatibility.
Work with teams early in development to understand future verification needs and develop methods that can be used to verify new system elements
Establish and manage shelf life of Insulet’s products, including verification testing in support of new products or design changes that have the potential to impact system performance, particularly shelf life or drug-device compatibility
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 Systems COE
Manage all aspects of the Insulet R&D lab, including establishing practices to assure compliance with Insulet’s standard operating procedures covering test equipment
Other duties within the scope of the Position Overview as assigned
Bachelor of Science or equivalent degree in Engineering; advanced degree preferred
Minimum of 15 years’ experience testing medical devices in a multidisciplinary project team environment
Test Engineering training and/or certification is a 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
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/
Street: 600 Technology Park Drive