Engineer Validation

Stryker Corporation; India; Hybrid; Confidential; Full time

Benefits offered by this job

Restaurant d'entreprise

Job summary

Stryker Corporation in India is seeking a Validation Engineer to support product and process introductions in a regulated manufacturing setting. You will participate in CSV activities, develop validation documentation, and coordinate IQ/OQ/PQ protocols across multiple equipment and software platforms.

The role requires a mechanical/industrial engineering background, 2+ years in a medical device or similar high-tech environment, and strong knowledge of GMP, FDA, ISO 13485 and risk management.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related field.
• Minimum 2 years of engineering experience in medical device manufacturing or regulated environments.
• Knowledge of GMP, FDA, ISO 13485 and risk management principles.

Responsibilities

• Support new product and process introductions per PDP and quality system requirements.
• Support CSV activities for manufacturing systems, software, automation, and digital tools.
• Develop and execute validation documentation including validation plans, risk assessments, test protocols and reports.
• Design, execute, and document IQ/OQ/PQ and related qualifications.
• Review 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, Control Plans, SOPs, PPAP.
• Conduct MSA and capability studies for new products and processes.
• Ensure compliance with regulatory, GMP, safety and environmental requirements.

Skills

Process validation

GD&T interpretation

Regulatory compliance

Risk management

Root cause analysis

Project management

Quality systems

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

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.

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.