Engineer Validation

Stryker Group; India; On-site; INR 700,000 - 1,100,000; Full time

Benefits offered by this job

Health insurance

Annual bonus

Job summary

Stryker Group seeks a quality engineering professional to support device validation, risk management, and regulatory compliance across manufacturing systems.

You will execute IQ/OQ/PQ activities, perform CSV for software and automation, and collaborate with Quality Engineering to ensure patient safety and product quality in a regulated environment.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related technical discipline.
• Minimum 2 years in medical device or regulated manufacturing.
• Understanding of manufacturing processes, equipment qualification, and process validation.
• Familiarity with GMP, FDA, ISO 13485, and risk management.
• Ability to read engineering drawings and GD&T.
• Experience with statistical tools and root-cause analysis.

Responsibilities

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

Skills

Manufacturing processes

Equipment qualification

Process validation

Regulatory knowledge

GD&T interpretation

Statistical tools

Root-cause analysis

Project management

Communication skills

Education

Bachelor's degree in Mechanical/Manufacturing/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.

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.