Systems Engineer, V&V - Acton, Mass. (Hybrid)

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.