Job Summary
1. Must: Experience in Design and Development of design test method validation (Variable and attribute), protocols, and report in accordance with global regulatory requirements.
2. Must: Experience on Variable data analysis using Minitab.
3. Must: Knowledge on medical device quality and design controls (FDA guidelines, ISO 13485, ISO 14971, and IEC 62366).
4. Must: Minimum 3+ yrs of relevant experience.
5. May: Experience in Design Test fixture using SolidWorks additional advantage.
Key Responsibilities
1. Develop and execute Test Method Validation (TMV) activities for both Variable and Attribute measurement systems.
2. Create validation protocols, test plans, and reports in compliance with global regulatory and quality requirements.
3. Perform variable data analysis using Minitab, including statistical evaluation of test methods and validation results.
4. Ensure validation activities comply with FDA Design Controls, ISO 13485, ISO 14971, and IEC 62366 requirements.
5. Support design verification activities by establishing robust and repeatable test methods.
6. Apply risk management principles during validation activities and ensure traceability to design requirements.
7. Maintain validation documentation, evidence, and records suitable for regulatory inspections and quality audits.
8. Work with R&D, Quality, Regulatory Affairs, and Product Development teams to support product development activities.
9. Design or support development of test fixtures using SolidWorks (desirable skill).
Skill Requirements
Test Method Validation (TMV) - Hands-on experience in developing and executing Variable and Attribute Test Method Validations.
Protocol & Report Writing - Ability to create validation protocols, statistical rationale, acceptance criteria, and final reports.
Minitab - Strong knowledge of statistical analysis using Minitab for validation studies.
Measurement System Analysis (MSA) - Experience with Gauge R&R, Bias, Linearity, Stability, Repeatability, and Reproducibility studies.
Variable Data Analysis - Capability to analyze continuous measurement data and establish method capability.
Medical Device Regulations - Knowledge of FDA Design Controls and medical device development processes.
ISO 13485 - Understanding of Quality Management System requirements for medical devices.
ISO 14971 - Knowledge of risk management principles and risk-based validation approaches.
IEC 62366 - Familiarity with usability engineering and human factors requirements.
Design Verification & Validation (DV&V) - Ability to support verification testing and validation activities.
Technical Documentation - Strong documentation and traceability practices for regulated environments.