Systems Engineer, Verification & Validation

Insulet Corporation

. Manage verification and validation activities and deliverables for new product development and sustaining products .

Posted 9/15/2026full-timeActon • Massachusetts • United StatesMid-LevelSenior💰 $77,300 - $116,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Verification and Validation processes for medical devices, including developing test plans, managing compliance with quality standards, and leading cross-functional teams. Proficient in utilizing RQM tools and familiar with FDA regulations and ISO standards relevant to medical device testing.

Highest-signal resume keywords

Verification & Validation Test ProgramsRQM Tools (DOORS, Helix, Jama)ISO 13485 ComplianceTechnical LeadershipBiomedical Engineering

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Requirements AnalysisTest Case DevelopmentRegression TestingTest MethodologiesConfiguration ManagementSystem-Level TestingQuality Management System (QMS)FDA-Regulated Device DevelopmentAnalytical SkillsProblem-Solving Skills

Soft Skills

Communication SkillsTeam CollaborationMentoring SkillsLeadership SkillsEngagement Skills

Tools & Technologies

Atlassian Tools (JIRA, Confluence, Bamboo)RQM ToolsDOORSHelixJama

Certifications & Qualifications

Test Engineering Certification

Industry Keywords

Medical DevicesDesign ControlsISO 9000IEC 62304IEC 60601ISO 14971Class 2 Medical DevicesClass 3 Medical Devices

About the role

Key responsibilities & impact

Manage verification and validation activities and deliverables for new product development and sustaining products
Develop detailed verification and validation plans and schedules
Perform requirements analysis and manage test cases and test runs using RQM tools, including DOORS, Helix, and Jama
Collaborate with Systems Engineering to ensure requirements are testable
Participate in planning and execution of technical project work
Create and document test methodologies and provide product/design feedback
Communicate with team members to ensure engagement and efficient operation
Analyze post-execution design changes to determine required regression testing
Provide technical consulting and mentoring to early-career Design Verification Test Team members
Manage third-party verification activities for compliance with applicable standards
Develop and update test cases, perform dry runs, and review coverage of typical, alternate, and negative paths
Maintain product configuration management for assigned projects
Perform verification testing according to prescribed test cases
Ensure compliance with Insulet quality policies, procedures, practices, and applicable regulations

Requirements

What you’ll need

Bachelor’s Degree required, preferably in Biomedical Engineering, Software Engineering, Computer Science, Mechanical Engineering, or Electrical Engineering
Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment, or an advanced degree and 1+ years of experience
Strong technical judgment and extensive technical leadership skills
Demonstrated capability of leading Verification & Validation Test Programs
Familiarity with Atlassian Tools (JIRA, Confluence, Bamboo)
Strong analytical and problem-solving skills
Ability to clearly communicate concepts, ideas, and knowledge to individuals and teams
Experience directing associates and leading small cross-functional teams
Familiarity with system-level testing of software-based medical devices
Experience working collaboratively under a Quality Management System (QMS) as part of a cross-functional team
Demonstrated skills developing and introducing innovative FDA-regulated Class 2 or 3 medical devices under Design Controls
Experience with processes conforming to ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971
Test Engineering training and/or certification is a plus

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Additional employee wellness programs
Incentive compensation eligibility