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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software verification and testing methodologies, with a strong focus on medical product compliance and quality assurance. Proficient in developing test protocols and managing test cases to ensure adherence to regulatory standards.
Highest-signal resume keywords
Software Verification ExperienceKnowledge Of Medical Product VerificationCreating Test ProtocolsExperience Using Test Case Management ToolsUnderstanding Of Good Documentation Practices
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Test PlansManual TestingWorkflow AnalysisQuality ImprovementsSoftware Defect Resolution
Soft Skills
Collaborative WorkProblem Solving
Tools & Technologies
MatrixPolarionTFSTestRailJAMA
Industry Keywords
IEC-62304FDA GuidanceQuality AssuranceRegulatory Needs
Tech Stack
Tools & technologiesTFS
About the role
Key responsibilities & impact- Test the functionality and performance of the systems software
- Develop and execute manual test plans and scripts designed to detect problems
- Maintain broad understanding of current testing software technologies
- Ensure systems software meets technical and functional requirements
- Perform workflow analysis, document test results and recommend quality improvements
- Work with engineers to resolve software defects and diagnose/improve product configuration for current and future models
- Support testing and quality assurance for the Affera Mapping and Ablation System medical device
- Work collaboratively with the Affera Software Team and other engineering teams
Requirements
What you’ll need- Bachelor's degree and 0 years of relevant experience
- Knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical discipline, preferably software related
- Software verification experience
- Strong understanding of creating test protocols for verifying software requirements
- Ability to work with QA to ensure testing meets Quality and Regulatory needs
- Strong understanding of good documentation practices
- Experience using a tool or repository for managing test cases (Matrix, Polarion, TFS, TestRail, JAMA etc.)
- Ability to manage, track and upgrade multiple hardware and software configurations
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level
Benefits
Comp & perks- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan