Senior Engineer Validation

Stryker Corporation; India; Hybrid; Confidential; Full time

Benefits offered by this job

Hybrid work model

Travel up to 20%

Job summary

Stryker Corporation in India seeks a seasoned Validation Engineer to support new product introductions, execute IQ/OQ/PQ protocols, and ensure compliance with GMP, FDA QSR, ISO 13485. You will collaborate with R&D, Manufacturing, Quality, Regulatory, and Operations to transfer products to manufacturing and support lifecycle validation.

The role requires a Bachelor's in engineering and 6+ years in validated environments; experience with CSV, risk assessments, and validation plans; strong

Qualifications

• Bachelor's degree in Mechanical, Electrical, Electronics, Industrial, Manufacturing or related technical discipline.
• 6+ years in Validation/Manufacturing/Quality engineering in regulated environments (medical devices/pharma).
• Hands-on IQ/OQ/PQ execution for equipment, processes, tooling, and systems.
• CSV knowledge and regulatory expectations (GMP, FDA 21 CFR Part 820, ISO 13485).
• Strong documentation, problem-solving and cross-functional collaboration.

Responsibilities

• Support new product introductions and process transfers per PDP, Design Controls and Quality System requirements.
• Lead IQ/OQ/PQ activities and related validation lifecycle management.
• Prepare Validation Plans, Risk Assessments, Protocols, and Final Reports; ensure traceability.
• Collaborate with R&D, Manufacturing, Quality, Regulatory, and Operations to industrialize products.

Skills

Validation engineering

Manufacturing engineering

Quality engineering

Regulatory awareness

Education

Bachelor's degree in engineering

Job description

Work Flexibility: Hybrid

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 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.

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.