Senior Engineer Validation

Stryker Group; India; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Stryker Group in India seeks a Validation Engineer with strong experience in medical devices. You will drive IQ/OQ/PQ, validate equipment and processes, and support risk assessments, validation planning, and lifecycle management to ensure regulatory compliance.

The role requires collaboration across R&D, Manufacturing, Quality, Regulatory, and Operations to transfer new products into manufacturing and to ensure readiness for production ramp-up.

Qualifications

• Bachelor's degree in an engineering discipline.
• 6+ years in Validation/Manufacturing/Quality in medical devices or similar regulated industries.
• Hands-on IQ/OQ/PQ execution experience.
• Experience reviewing test requirements from product requirements and EOL tester qualification.
• Working knowledge of CSV methodologies and regulatory expectations.
• Strong GMP, FDA 21 CFR 820, ISO 13485, ISO 60601 knowledge.

Responsibilities

• Support product/process introductions per PDP, Design Controls, and Quality System requirements.
• Collaborate with R&D, Manufacturing Eng, Quality, Regulatory, and Operations to transfer products to manufacturing.
• Participate in readiness activities including pilot builds, process characterization, verification, and ramp-up.
• Develop and maintain validation documentation: validation plans, risk assessments, protocols, traceability matrices, final reports.
• Lead IQ, OQ, and PQ activities for manufacturing equipment, processes, tooling, fixtures, and production systems.
• Support Master Validation Planning and lifecycle management.
• Ensure validation activities comply with GMP, FDA QSR, ISO 13485, ISO 60601, and internal quality requirements.

Skills

Validation engineering

GMP & FDA 21 CFR 820

Quality systems

Cross-functional collaboration

Problem solving

Project management

Documentation

Education

Bachelors in Engineering (Mechanical/Electrical/Electronics/Industrial/Manufacturing)

Tools

Minitab

CSV methodologies

IQ/OQ/PQ protocols

Job description

What you will do:

• Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements.
• Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing.
• Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up . Should have strong understanding of the difference between verification and validation.
• Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports.
• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems.
• Support Master Validation Planning and validation lifecycle management activities.
• Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.

What you will need:

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
• Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or a related discipline within medical devices, pharmaceuticals, biotechnology, or other regulated industries.
• Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems.
• Experience with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation.
• Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations.
• Strong understanding of GMP, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 60601, and risk management principles.

Preferred Qualification:

• Experience with PFMEA, Control Plans, PPAP, and process qualification methodologies.
• Working knowledge of MSA, Gage R&R, process capability analysis, and statistical tools such such as Minitab.
• Experience supporting New Product Development (NPD), design transfer, and manufacturing scale-up activities.
• Strong problem-solving, project management, and technical documentation skills.
• Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams.