Engineer Validation

Stryker Corporation; Gurugram District; Hybrid; INR 650,000 - 900,000; Full time

Job summary

Stryker Corporation in Haryana, Gurugram District is seeking an engineer to support new product and process introductions under PDP and the quality system. You will develop and execute validation documentation, participate in CSV activities for manufacturing, automation, and digital tools, and ensure compliance with GMP, FDA, ISO 13485, and risk management requirements.

The role offers hybrid/onsite flexibility, travel up to 20%, and a focus on quality, process validation, MSA, PPAP, and

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.

Responsibilities

• Support new product and process introductions in PDP and quality system requirements.
• Support 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 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 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.

Education

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline

Job description

Work Flexibility: Hybrid or Onsite

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.

What you will need:

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.

Travel Percentage: 20%

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.