Senior Engineer, GPE Lifecyle Management

Stryker Corporation; India; Hybrid; Confidential; Full time

Job summary

Stryker Corporation is seeking a Product Engineer within the Global Product Engineering team in India. You will gain in-depth knowledge of Trauma & Extremities products and drive design changes while ensuring compliance with FDA, EU MDR, and ISO 13485 standards.

You will collaborate with Regulatory Affairs, Tech Publications, and Marketing to support global registrations and technical files. The role focuses on design optimization, continuous improvement, and effective CAPA/NC management, with

Qualifications

• Bachelor's or master's degree in mechanical engineering, biomedical, or related field.
• 4–7 years of engineering experience.
• 2+ years in the medical device industry with sustaining engineering exposure.

Responsibilities

• Work within Global Product Engineering to learn and improve design specifications and performance.
• Lead and participate in design change management activities and regulatory submissions.
• Support internal and external audits as a subject matter expert on design-related questions.
• Oversee NC/CAPA investigations and cross-functional teams for corrective actions.
• Develop and manage project plans and cross-functional collaboration with Regulatory Affairs, Tech Publications, Design Quality, and Marketing.

Skills

NC/CAPA processes

CAD proficiency

PLM proficiency

Strong communication

Education

Bachelors or Masters in mechanical/biomedical engineering

Tools

Creo

Windchill

ANSYS

Job description

Work Flexibility: Hybrid

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

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.

Travel Percentage: None

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.