Design Control Engineer IRC268542

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.

#LI-AR1

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.

 

What we offer

Culture of caring. At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders. 

Learning and development. We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work. GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.

Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!

High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

About GlobalLogic

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.