Senior Engineer, GPE Lifecyle Management

Stryker Group; Gurugram District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Stryker Group in India is seeking a Mechanical/Biomedical Design Engineer to join the Global Product Engineering team, supporting Trauma & Extremities products such as bone plates, screws, and instruments. You will ensure design specifications meet regulatory and quality requirements and contribute to design change management and CAPA activities.

You will collaborate with Regulatory Affairs, Tech Publications, Design Quality, and Marketing to prepare technical files for EU MDR registrations and

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.
• 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.

Responsibilities

• Maintain and improve design specifications and performance.
• Ensure regulatory compliance with FDA, EU MDR, ISO 13485, and internal standards.
• Drive design change management and support regulatory submissions.
• Lead cross-functional teams on NC, CAPA, and change initiatives.
• Collaborate with Regulatory Affairs, Tech Publications, Design Quality and Marketing for registrations and technical files.
• Drive value improvement, design optimization, and cost effectiveness.

Skills

NC/CAPA

CAD

PLM

Engineering fundamentals

Communication skills

Education

Bachelor's or Master's in Mechanical/Biomedical

Tools

Creo

Windchill

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