Senior Engineer, GPE Lifecyle Management

Stryker; Gurugram District; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Stryker in India seeks an experienced Mechanical/Biomedical engineer to join the Global Product Engineering team, focusing on Trauma & Extremities products. You will work on bone plates, screws, external fixators, and instruments, helping ensure design excellence and regulatory readiness.

Responsibilities include maintaining 50,000+ articles, conducting design change management, supporting regulatory submissions, CAPA investigations, and cross-functional collaboration across international teams

Qualifications

• Experience in NC/CAPA and change management processes (ECN/ECR).
• Proficient with CAD and PLM system.
• Strong understanding of engineering fundamentals, product design, and risk-based decision making.
• Strong written and verbal communication skills.

Responsibilities

• Gain in-depth knowledge of Stryker’s Trauma & Extremities portfolio and products.
• Maintain and improve design specifications and performance for 50,000+ articles.
• Ensure compliance with FDA, EU MDR, ISO 13485 and internal standards; drive design change management and regulatory submissions.
• Apply design change processes and identify technical solutions.
• Lead or participate in cross-functional teams for NC, CAPA and related actions.
• Coordinate with Regulatory Affairs, Technical Publications, Design Quality and Marketing for registrations and technical files for EU-MDR.
• Drive value improvement, design optimization, and cost-efficient performance.

Skills

NC/CAPA & change mgmt

CAD

PLM systems

engineering fundamentals

communication skills

Education

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

Tools

Creo

Windchill

ANSYS

Job description

What You Will Do / Roles & Responsibilities

• As a member of the Global Product Engineering team you will gain in depth knowledge about Stryker’s Trauma & Extremities portfolio. You will learn how Bone Plates & Screws, External Fixators, Surgical Instruments and many other products improve people’s life.
• Together we are responsible for over 50'000 articles. We count on you to maintain and improve our high standard in design specification and performance.
• You ensure compliance with applicable regulatory and quality requirements, including FDA, EU MDR, ISO 13485, and internal standards, by driving design change management activities, support regulatory submissions, and serving as a subject matter expert during internal and external audits.
• In your field of responsibility, you will make sure that design requirements are met as well as apply the design change process and identify technical solutions in this context.
• You oversee the continuous improvement projects for existing products in our group, create and manage project plans, assign and follow up on work packages. You participate in and at times lead cross functional teams to perform design related Non-Conformities(NC), Corrective- and Preventive-Actions(CAPA).
• Your role will include frequent contact with other teams such as the international Regulatory Affairs, Tech. Publications, Design Quality or Marketing to address design related questions for international registrations and creations of technical files required for the implementation of EU-MDR requirements.
• Drive value improvement, design optimization, and continuous improvement initiatives to enhance product performance, quality, compliance, and cost effectiveness.

What You Need

Required

• Experience in NC/CAPA and change management processes (ECN/ECR).
• Proficient with CAD and PLM system.
• Strong understanding of engineering fundamentals, product design, and risk-based decision making.
• Strong written and verbal communication skills.

Minimum Qualifications

• Bachelor’s or master’s degree in mechanical engineering or biomedical or related & 4-7 years of work experience
• Minimum 2+ years of medical device industry experience with exposure to sustaining engineering activities.

Preferred

• Experience with Creo and Windchill is highly desirable.
• Knowledge of FEA tools (e.g., Ansys), materials, and manufacturing processes.
• Experience managing product obsolescence projects for a large portfolio

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.