Software Quality Engineer with Medical Device experience IRC287743

Description

The client is a pioneer in medical devices for less invasive surgical procedures, ranking as a leader in the market for coronary stents. The company’s medical devices are used in a variety of interventional medical specialties, including interventional cardiology, peripheral interventions, vascular surgery, electrophysiology, neurovascular intervention, oncology, endoscopy, urology, gynecology, and neuromodulation.
The client’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare.

The Software Quality Engineer will use electrical/software experience to support, develop, establish and maintain risk management and design control documentation throughout the Software Development Lifecycle (SDLC). Experience in Software as a Medical Device (SaMD), complex Medical Electrical Equipment/Systems (MEE / MES), IEC 62304 or IEC 82304 is preferred.

As part of the GlobalLogic team, you will grow, be challenged, and expand your skill set working alongside highly experienced and talented people.

If this sounds like an exciting opportunity for you, send over your CV!

Requirements

• Minimum of a bachelor’s degree in electrical engineering, computer science, softwareengineering, or a related field
• Minimum of 5 years of medical device engineering experience or other regulated
  industry experience
• Understanding and practice of the FDA, ISO and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering.
• Experience in one or more of the following areas:
• Experience with Software as a Medical Device (SaMD) and/or systems
  integration
• Experience in Medical Electrical Equipment/Systems (MEE / MES)
• Experience in IEC 62304 and/or IEC 82304
• Strong communication and presentation skills

Job responsibilities

• Drive and execute ISO 14971 risk management process, Verification & Validation (V&V) process and support software applications throughout the Software Development
• Lifecycle (SDLC) per IEC 62304, IEC 82304 or equivalent standard. Relevant activities include but are not limited to risk controls development, assessment and risk mitigations.
• Create and maintain risk management and usability documentation such as, PHA, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Software Safety Classification incorporating ISO 14971, IEC 62304 and IEC 82304
  principles.
• Support software verification/validation activities and associated documentation. Relevant activities include participation in test strategy design, development of test plans and test cases and peer review of test code written in python or similar programming languages.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing,
  communicating, and resolving quality issues.

 

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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.