Senior Advanced Quality Engineer

PowerToFly; Gurgaon; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Stryker, a global medical technologies leader, is seeking a Design Quality Engineer for orthopedic devices in India. The role emphasizes risk management, usability engineering, and design controls across product development lifecycles.

You will collaborate with Regulatory, Quality, Clinical, Manufacturing, and Packaging teams to ensure compliance and drive quality improvements. Prior experience in regulated environments is essential.

Qualifications

• Bachelor's or master's in mechanical engineering, biomedical or similar domain.
• 4–7 years of experience.
• Experience in regulated environments (FDA QSRs, ISO 13485 Design Control, IEC 62366-1, ISO 14971) and with PLM, Jama, JIRA.
• Knowledge of advanced quality tools: FMEA, GD&T, Root Cause Analysis, and Mistake Proofing.

Responsibilities

• Support New Product Development (NPD) Design Quality Engineering activities focusing on risk management, usability engineering and design control.
• Collaborate with cross-functional partners ensuring compliance throughout development.
• Lead risk management and usability activities per standards and internal procedures, driving mitigation.
• Drive continuous improvement to quality, efficiency, and consistency of deliverables.

Education

Bachelor's or Master's in Mechanical Engineering, Biomedical or related field

Tools

PLM tools

Jama

JIRA

FMEA

GD&T

Root Cause Analysis

Mistake Proofing

Job description

What you will do-

• Support New Product Development (NPD) Design Quality Engineering activities for orthopedic medical devices, with a primary focus on risk management, usability engineering and design control as per the project and business need.


• Effectively collaborate with cross functional partners (Product Development, Regulatory Affairs, Quality, Clinical, Manufacturing, Packaging, Sterility, etc. and ensure compliance with applicable Quality System and regulatory requirements throughout the development process.


• Lead risk management and usability activities in accordance with applicable standards and internal procedures including formative and summative evaluations. Drive identification, assessment, and mitigation of product and process risks.


• Drive continuous improvement initiatives and identify opportunities to improve quality, efficiency, and consistency of deliverables.

What you will need-

Required skills-

• Bachelor's or master’s in mechanical engineering, bio-medical or similar domain.


• Experience- 4 years -7 years


• Experience of working in regulated environment such as FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971 and experience with Product Lifecycle Management (PLM) tools, requirement management tools (Jama etc) and project management tools (JIRA etc)


• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing.

Preferred skills-

• Knowledge of EU Medical Device Regulation preferred


• Familiarity with design reviews and Design History File (DHF) documentation creation and organization.


• Experience with 3D CAD software, especially Creo from PTC and experience with surgical trays.

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.