Senior Validation Engineer

Senior Validation & Verification Engineer will be responsible for planning, executing, and overseeing the validation and verification processes for products. This role ensures that all products meet industry standards, regulatory requirements, and customer expectations.

Key Responsibilities:

Validation & Verification Activities:

• Develop and implement V&V plans, test protocols, and test cases for new and existing products.
• Execute functional, performance, environmental, and reliability testing on instruments.
• Analyze test results, identify deviations, and collaborate with design teams to resolve issues.
• Document test reports and ensure traceability of requirements to test cases.
• Work on software and hardware validation as per industry standards.

Compliance & Quality Assurance:

• Ensure compliance with ISO 9001, ISO 17025, IEC 61010, IEC 61508 (Safety), or other relevant regulatory standards.
• Support risk analysis (FMEA, DFMEA, PFMEA) to identify potential failures and mitigation strategies.
• Ensure that all validation processes adhere to FDA, CE, and other regulatory requirements, if applicable.

Process Improvement & Documentation:

• Participate in design reviews to provide early-stage feedback on product verification strategies.
• Work closely with R&D, Manufacturing, and Quality teams to enhance validation processes.
• Develop and maintain Standard Operating Procedures (SOPs) related to V&V.

Automation & Tools:

• Implement automated test scripts and frameworks for V&V where applicable.
• Utilize test management tools (e.g., Modscan, Modbus Poll, LabVIEW, VB, etc.) to enhance efficiency.

Qualifications & Experience:

• Bachelor’s/Master’s degree in Electrical, Electronics, Instrumentation, or related fields.
• 5+ years of experience in V&V within an instrumentation, medical devices, or industrial automation domain.
• Hands-on experience in hardware, firmware, and software testing of industrial instruments.
• Familiarity with sensor-based technologies, HMI, PLC/DCS systems, and IoT-enabled devices is a plus.
• Experience with regulatory audits and certification processes is preferred.

Preferred Certifications (if applicable):

• Certified Test Engineer (ISTQB or equivalent).
• Six Sigma Green Belt (for process improvement).
• Certifications in IEC/ISO regulatory standards.

Job Type: Full-time

Pay: ₹40,000.00 - ₹70,000.00 per month

Benefits:

• Provident Fund

Schedule:

• Day shift

Education:

• Bachelor's (Required)

Experience:

• Firmware: 3 years (Required)

Language:

• English (Required)

Location:

• Mulund West, Maharashtra (Required)

Willingness to travel:

• 100% (Required)

Work Location: In person