Senior Technical Writer IRC270953

Description

Product Development team is seeking an experienced Technical Writer/Human Factors Engineer to enhance product usability and safety through assessment and validation. You’ll play a pivotal role within Customer Human Factors Center of Excellence, charting the course for the company’s capabilities, and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

Our client is innovative manufacturer of medical devices in the United States which produces a devices and software applications.

At this project, you will have a great opportunity to be involved into the full development life cycle of medical software which is intended to help individuals by processing certain information taken from medical devices to identify health trends and to track daily activities. As additional there are opportunities to work with medical devices, in scope of end-to-end testing.

Requirements

• 3+ years as Technical Writer experience in design-controlled processes, specifically in regulated domains like medical devices.
• Skilled in deriving conclusions from study data and conducting effective root cause analyses.
• Demonstration of exceptional technical problem-solving, interpersonal, and communication skills (verbal and written).

Will be a plus:

• Understanding regulatory requirements, possess strong knowledge of medical device design and FDA guidelines, and be familiar with HE75 and IEC 62366-1, -2.
• Cross-functional experience in risk management activities, including FMEA expertise.
• Proficient in leading Human Factors processes, including study design, moderation, and execution.
• Available for up to 25% travel, including both domestic and international trips (must be cleared for international travel).

Job responsibilities

• Strategize, execute, and document usability engineering evaluations, including task analyses and human factors studies.
• Author formative and summative usability study protocols
• Plan, coordinate, and moderate formative and summative usability studies.
• Perform root cause analysis of use errors and aggregate data for presentations and formal reports.
• Author and update usability risk analyses in collaboration with cross-functional stakeholders.
• Collaborate with Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation.
• Partner with Quality teams to address complaints related to usability on-market products.
• Work with design teams to create patient-centric and compliant designs.
• Assist in developing usability engineering processes for Quality system improvements.
• Support inquiries, audits, and discussions with regulatory agencies.

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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.