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 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
- 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 the product is fully compliant with all applicable standards (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:
Requirements:
- Bachelors’ Degree - Required (preferred field of study: Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or any equivalent degree)
- 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience
- Experience working with tools for managing requirements, test cases and defects such as or similar to: JIRA, Polarion, Helix or related quality management system tools
Preferred Skills and Competencies:
- Technical judgement using technical leadership skills
- Story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process
- Strong Analytical and Problem-Solving Skills
- Clearly communicate concepts, ideas and knowledge to other individuals and teams
- Directing associates and leading small cross-functional teams
- 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
- 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 $75,375.00 - $113,062.50. 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.
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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What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ 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
