QUALIFICATIONS

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Software, or related field).
• 5–8 years of experience in product testing, verification/validation, or quality engineering in a regulated industry (medical device, pharma, diagnostics).
• Working knowledge of FDA regulations, ISO 13485, IEC 60601, ISO 14971, and related compliance standards.
• Experience in remediation projects, gap assessments, and test documentation for regulatory approval.
• Strong analytical and problem-solving skills with attention to detail.
• Hands-on experience with test equipment, automation tools, and laboratory practices.
• Excellent written and verbal communication skills for preparing regulatory-compliant documentation.

PREFERRED SKILLS

• Experience in FDA submissions (510(k), PMA, De Novo) or supporting documentation.
• Familiarity with software testing (21 CFR Part 11, IEC 62304) if applicable.
• Knowledge of risk management and reliability testing methodologies.
• Previous involvement in remediation programs for FDA/Notified Body audit findings.

ROLE OVERVIEW

The Test Engineer will be responsible for planning, executing, and documenting product testing activities required for FDA approval, compliance, and remediation efforts. The role ensures that products meet regulatory, quality, and safety requirements by executing validation protocols, analyzing test results, and supporting remediation of non-conformances.

KEY RESPONSIBILITIES

• Develop, execute, and document test protocols, procedures, and reports in alignment with FDA and ISO regulatory requirements (e.g., 21 CFR Part 11, 21 CFR Part 820, ISO 13485).
• Conduct functional, performance, verification, and validation testing of products, ensuring compliance with design inputs and regulatory standards.
• Support remediation activities by identifying product gaps, executing additional testing, and providing objective evidence for compliance.
• Perform root cause analysis and support corrective and preventive actions (CAPA) for product issues discovered during testing.
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure testing covers all aspects of compliance and safety.
• Maintain accurate test records, traceability matrices, and defect documentation to support regulatory submissions and audits.
• Ensure test equipment is properly calibrated, validated, and maintained per FDA and internal quality system requirements.
• Participate in regulatory audits, inspections, and reviews, providing technical support and test evidence.
• Continuously improve testing methodologies and contribute to risk management activities (FMEA, hazard analysis).