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!
The Systems Engineer V&V will be a member of the Systems Engineering COE responsible for Systems Engineering activities related to verification and validation of Insulet’s products.
The position will report to the Manager Systems Design Verification located at Insulet’s office in Tijuana, Baja California, Mexico.
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.
· Collaborate with Systems Engineering to ensure that all requirements are testable
· Develop, review, implement and maintain test strategies, test protocols and test cases for system verification.
· 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)
· Perform and maintain product configuration management for assigned projects
· Perform verification testing following prescribed Test Cases for assigned projects.
· Other duties within the scope of the Position Overview as assigned
· Ensure compliance with regulatory standards and Insulet quality policies, procedures and practices
Education and Experience:
· 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
· Experience working with a requirements management tool (Helix, Jama, and/or Polarion), quality management system tool, test case management tool and, defect management tool
Preferred Skills and Competencies:
· Strong technical judgement with technical leadership skills
· 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
· Demonstrated skills testing 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
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. Omnipod products are offered in 25 countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov.
