Design Control Engineer

Description

A global leader in surgery with products and solutions found in almost every operating room around the world, and has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

Requirements

• At least 4-5 years of quality management work experience.
• Knowledge and understanding of ISO 9001 series and ISO 13485 standards.
• Knowledge and understanding of regulations on medical device manufacturing (at least US FDA Regulations).
• Knowledge of the software development life cycle (work experience in software development or knowledge of the international standards that regulate this process such as IEC 62304 standard).
• Experience with Software Risk Management (ISO 14971) is a big plus.
• Fundamentals of software testing and quality assurance.
• Fundamentals of FTA/FMEA/FMECA methodologies.
• Knowledge of the QMS structure.
• Experience of participation in internal and external audits.
• Strong documentation management skills.
• Ability to work with standards. Ability to comprehend a new document with standards, analyze it well enough to assess the standards’ value/benefit for the Company against possible risks entailed.
• English at the upper intermediate level.
• Presentation and training skills.
• Ability to coordinate and lead meetings in a team and with other participants.

Job responsibilities

• Establish process and documentation to validate the Test Automation Framework and Scripts in compliance with Client’s SOPs (SW SOP, CSV SOP etc.)
• Create the validation plan and drive the GL Test Automation team to follow those processes and create corresponding documentation/deliverables.
• Review GL generated deliverables to ensure accuracy and completeness.
• Work with Client’s QA and Leads for approvals of deliverables.