Senior Engineer, GPE Lifecyle Management

What You Will Do / Roles & Responsibilities

• As a member of the Global Product Engineering team you will gain in depth knowledge about Strykers Trauma & Extremities portfolio. You will learn how Bone Plates & Screws External Fixators Surgical Instruments and many other products improve peoples life.

• Together we are responsible for over 50000 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

    • Bachelors or masters 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