Engineer Validation

Stryker; Gurugram District; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Stryker in India (Gurugram area) seeks an engineer to support new product and process introductions within PDP and quality systems. You will contribute to developing and executing validation plans, risk assessments, and documentation for successful product launches.

The role involves validating manufacturing systems, software, automation, and digital tools; designing IQ/OQ/PQ; and collaborating with Quality Engineering to ensure patient safety and regulatory compliance across operations.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial engineering or related technical discipline.
• Minimum 2 years of engineering experience in medical device or regulated manufacturing.
• Strong understanding of manufacturing processes, equipment qualification, and validation methodologies.
• Knowledge of GMP, FDA, ISO 13485 and risk management principles.
• Ability to interpret engineering drawings and GD&T.
• Experience with statistical tools and process capability analysis; root-cause problem solving.

Responsibilities

• Support new product and process introductions per PDP and quality system requirements.
• Support CSV activities for manufacturing systems, software, automation, and digital tools per regulatory requirements and procedures; develop validation documentation.
• Design, execute, and document IQ/OQ/PQ for processes and equipment.
• Review, approve, and maintain validation and technical documentation.
• Collaborate with Quality Engineering to establish inspection methods, test protocols, and acceptance criteria.
• Support risk management activities, including PFMEA development, Control Plans, SOPs, and PPAP documentation.
• Conduct Measurement System Analysis and capability studies for new products and processes.
• Ensure compliance with regulatory, GMP, safety, and environmental requirements.

Skills

Project management

Organizational skills

Multitasking

Communication skills

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Industrial Engineering

Job description

What you will do

• Support new product and process introductions in accordance with Stryker’s Product Development Process (PDP) and quality system requirements.
• Support Computer System Validation (CSV) activities for manufacturing systems, software applications, automation solutions, and digital tools in accordance with regulatory requirements and company procedures. Develop and execute validation documentation, including validation plans, risk assessments, test protocols, and reports.
• Design, execute, and document process qualifications, equipment qualifications, and validation activities (IQ/OQ/PQ).
• Review, approve, and maintain validation and technical documentation.
• Collaborate with Quality Engineering to establish inspection methods, test protocols, and acceptance criteria for components and finished products.
• Support risk management activities, including PFMEA development, Control Plans, SOPs, and PPAP documentation.
• Conduct Measurement System Analysis (MSA) and capability studies for new products and manufacturing processes.
• Ensure compliance with applicable regulatory, GMP, safety, and environmental requirements.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum 2 years of engineering experience in medical device, regulated manufacturing, or a similar high-technology environment.
• Strong understanding of manufacturing processes, equipment qualification, and process validation methodologies.
• Knowledge of quality and regulatory requirements, including GMP, FDA, ISO 13485, and risk management principles.
• Ability to interpret engineering drawings, specifications, and Geometric Dimensioning & Tolerancing (GD&T).
• Experience with statistical tools, process capability analysis, and root-cause problem-solving methodologies.

Preferred Qualifications

• Strong project management, organizational, and multitasking skills.
• Excellent communication and interpersonal skills with the ability to collaborate effectively across multidisciplinary teams.
• Self-motivated, results-oriented professional with a continuous improvement mindset.
• High attention to detail and commitment to product quality and patient safety.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.