Description
Job Description : System Verification Engineer
Job Summary
The primary responsibility of the System Verification Engineer is to take a leading role in planning and executing verification tests during the development of new and existing products. This will involve developing test plans & procedures based on product and user requirement specifications and performing tests accordingly. This is a vital role in ensuring the quality of new and updated products and is an integral part of our product ideation process, following the development of an idea to a final product.
This role will require theoretical analysis, practical laboratory work, and a technical background that enables designing test procedures, test setups, and providing test reports.
The System Verification Engineer is a key member of the Engineering team and participates in all product development phases. Key responsibilities include the design and execution of verification strategies for manual and automated testing, design, implementation, testing, and modifying of Software for test automation. The System Verification Engineer may also be assigned to focus their activities on existing product lines to make improvements to Verification activities. This individual must have strong technical skills complemented by great communications and teamwork qualities. Experience in medical device product development or in a structured / regulated environment such as medical device development is required.
Responsibilities
System Verification Engineer I
- Follows design verification test plans.
- Basic knowledge of common test tools
- Executes manual or automated tests for verification and validation of finished medical devices
- Designs and executes integration and system test cases
- Collects appropriate data associated with test execution.
- Uses standard tools and processes for version control and configuration management.
- Contributes to requirements definition at the functional level
- Complies with all company policies and procedures
- Assists with any other duties as assigned
System Verification Engineer II
In addition to items listed for System Verification Engineer I, a System Verification Engineer II may also be responsible for the following :Works with other engineers and leads parts of the verificationDesigns and implements System- and System Software test plansDefinition of test setup and tool usageDevelops automated test casesGenerates required product development documentation including functional specifications and test reportsSystem Verification Engineer III
In addition to items listed for System Verification Engineer II, a System Verification Engineer III may also be responsible for the following :Instills a culture of producing high quality productsEstablishes quality standards for the project.Identifies project test objectivesIdentifies test success and failure criteria and completion criteria.Identifies testing tools and test data warehousesIdentifies opportunities for test automationEvaluates test effectiveness and identifies appropriate improvementsMentors less experienced engineersReviews engineering artifacts and test reports for accuracy and completeness, following good documentation practicesSystem Verification Engineer IV
In addition to items listed for System Verification Engineer III, a System Verification Engineer IV may also be responsible for the following :Defines organization wide verification strategy, tools, and documentationContinuously improves verification techniques, tools, and strategiesParticipates in creating and maintaining budgets for projects and the Systems Engineering departmentBe financially responsible for purchases and expenses related to System verification tools and systemsKnowledge, Skills, and Abilities
Must have strong work ethicExcellent oral and written communication skills requiredAttention to detail with accurate and complete documentationEffective conflict resolutionAnalytical & problem-solving skillsSolutions-oriented problem solverLead and execute exploratory test activities as part of product ideation and improvement activitiesDevelop test setups using test and data acquisition equipment for measuring system performanceDevelop and execute system verification plans and document the test results for inclusion in the product design history fileSupport failure mode analysis and root cause investigations and contribute to developing technical solutionsEngage with different product stakeholders to understand customer needs and design specifications, and translate these into test specificationsDesign test cases to include test methodology, test setups, materials, procedures, requirements, and acceptance criteriaLead the development of verification processes and scouting for verification toolsPerform all tasks in accordance with ISO and design control requirementsQualifications
Level I
Bachelor's in Engineering or related technical discipline, required0-3 years of experience in system and / or software verification requiredFollows design verification test plans.Basic knowledge of common test toolBasic knowledge / proficiency in test planning and verification protocol writingBasic knowledge / proficiency in tools for version control and configuration managementBasic knowledge / proficiency in ISO 9001, ISO 13485, IEC 14971 preferredA combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilitiesMedical device manufacturing experience, preferredLevel II
Bachelor's in Engineering or related technical discipline, required3-5 years of experience in system and / or software verification, requiredAdvanced knowledge of common test toolAdvanced knowledge / proficiency in test planning and verification protocol writingIntermediate knowledge / proficiency in test automationIntermediate knowledge / proficiency in requirements managementAdvanced knowledge / proficiency in ISO 9001, ISO 13485, ISO 14971, requiredA combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilitiesLevel III
Bachelor's in Engineering or related technical discipline, requiredMS Engineering or PhD, preferred5-8 years of experience in medical device engineering, requiredAdvanced knowledge of common test toolsAdvanced knowledge / proficiency in test automationAdvanced knowledge / proficiency in verification processesIntermediate knowledge / proficiency in medical device quality processesIntermediate knowledge / proficiency in test architectureAdvanced knowledge / proficiency in requirements managementAdvanced knowledge / proficiency in ISO 9001, ISO 13485, IEC 14971, requiredIntermediate knowledge of design control processes in the medical device industryA combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilitiesLevel IV
Bachelor's in Engineering or related technical discipline, requiredMS Engineering or PhD, preferred8-10 years of experience in system and / or system software verification, requiredExpert knowledge / proficiency in test automationAdvanced knowledge / proficiency in test architectureAdvanced knowledge / proficiency in ISO 9001, ISO 13485, IEC 62304, ISO 14971 requiredAdvanced knowledge / proficiency in medical device quality processesAdvanced knowledge of software deployment processes in the medical device industryA combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities