Planet Pharma
From Planet Pharma's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Top 3 technical skills that are required for the role: 1.
1. Knowledge of Verification and Validation Processes and Test Method Validation Experience.
2. Technical Writing and Documentation
3. Attention to detail
Education Required: 2 yrs with university degree
Years’ Experience Required: University Degree and minimum of 2 years of relevant experience
The Medical Device Software Verification & Validation Engineer is responsible for planning, executing, and documenting software testing, test method validation, and verification and validation activities for regulated medical devices. This role ensures that software and associated test methods meet design specifications, product requirements, risk controls, and applicable quality and regulatory standards. The engineer collaborates with cross-functional partners across Research and Development, Quality, Manufacturing, and Regulatory functions to deliver reliable, compliant, and audit-ready results.
Verification & Validation
Plan and execute verification and validation activities to demonstrate that medical device software meets approved design inputs, functional requirements, performance expectations, and regulatory requirements.
Develop, review, and execute V&V protocols; analyze results; investigate anomalies; and prepare clear, technically sound reports.
Conduct black-box, white-box, integration, and system-level testing for embedded systems and medical device software.
Maintain bidirectional traceability among software requirements, identified risks, test cases, test results, defects, and corrective actions.
Partner with Research and Development and Quality teams to troubleshoot and resolve issues identified during testing.
Test Method Validation
Develop and execute Test Method Validation protocols to confirm that test methods are accurate, repeatable, reproducible, and suitable for their intended use.
Perform Gauge R&R studies, analysis of variance, and other statistical analyses to evaluate measurement system performance and test method capability.
Define acceptance criteria based on engineering requirements, product risk, intended use, and applicable regulatory expectations.
Identify sources of variation, troubleshoot test method issues, and recommend corrective actions that improve reliability and consistency.
Collaborate with stakeholders to align test methods with product design, software development, and manufacturing needs.
Prepare comprehensive validation reports that support audits, design control documentation, and regulatory submissions.
Risk Management
Work with cross-functional teams to identify product and process risks and implement appropriate mitigation strategies.
Integrate risk controls and risk-based testing into V&V and TMV planning and execution.
Document risk assessments and maintain traceability between identified hazards, risk controls, verification evidence, and mitigation actions.
Required Qualifications
Bachelor’s degree in software engineering, electrical engineering, biomedical engineering, computer science, or a related technical discipline, or equivalent relevant experience.
Experience with software testing, verification and validation, or test method validation in a regulated product-development environment.
Working knowledge of software testing methodologies, requirements traceability, defect management, and design controls.
Demonstrated ability to apply statistical methods, interpret data, troubleshoot technical problems, and communicate results through clear technical documentation.
Core Competencies
Verification and validation planning and execution
Test method validation and statistical analysis
Software testing, debugging, and defect investigation
Risk assessment and requirements traceability
Technical writing and regulatory compliance
Data interpretation, analytical thinking, and structured problem-solving
Cross-functional collaboration and clear communication
Continuous improvement and engineering innovation
Scores your resume against this job the way resume scanners do: the job's hard and soft skills, searchability, recruiter tips and formatting.
Create a free account to see your score. Your resume stays in this browser until then, and we never store it.
Already a member? Sign in