Senior Advanced Quality Engineer

Stryker; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Stryker India in Gurugram is seeking an experienced Design Quality Engineer to support New Product Development for orthopedic devices, focusing on risk management, usability engineering and design controls. You will collaborate with Product Development, Regulatory Affairs, Quality and Manufacturing to ensure compliance throughout the development lifecycle.

The role requires 4–7 years in a regulated environment (FDA QSRs, ISO 13485), hands-on with FMEA, GD&T, RCA, and experience with PLM tools

Qualifications

• :Bachelor's or master's in mechanical engineering, biomedical or similar domain.
• :

Responsibilities

• 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.

Skills

Risk management

Usability engineering

Quality engineering

Regulatory compliance

FMEA

Root Cause Analysis

GD&T

Mistake Proofing

Education

Bachelor's or master's in mechanical/ biomedical engineering

Tools

Jama

JIRA

PLM

Creo (CAD)

Job description

• 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 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.