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Spoločnosť GlobalLogic Inc., člen skupiny Hitachi a líder vo vývoji digitálnych produkt...

Technical Project/Program Management
3-5 years
United States - San Jose CA
Healthcare-Medical Devices, IEC 62304:2006, ISO 13485:2012, Project Management, Project Management Office, requirements gathering & documentation, Technical Documentation
Remote
Note: GlobalLogic estimates the starting pay range for this role to be performed remotely in USA is $75,000 – $80,000 and reflects base salary only. This pay range is provided as a good faith estimate and the amount offered may be higher or lower. GlobalLogic takes many factors into consideration in making an offer, including candidate qualifications, work experience, operational needs, travel and onsite requirements, internal peer equity, prevailing wage, responsibilities, and other market and business considerations.
Project Management Coordinator, PMO Coordinator, Documentation Support Specialist reporting into R&D PMO within Medtech company
We are seeking a detail-oriented, process-driven Project Management Coordinator to join the R&D PMO team. In this role, you will be the backbone of the Design History File (DHF) and work under a Technical Program Manager. You will work directly with R&D to ensure that Product and Non-Product software meet regulatory compliance. This is a high-impact role requiring a blend of project management support, document control mastery, and the ability to drive accountability across cross-functional teams.
Design History File/Documentation/DHF/CSV Lifecycle Management: Own the end-to-end administrative process for DHF deliverables. This includes creating Info Cards, initiating Change Requests, and managing document “packets” within MasterControl.
Milestone Tracking: Maintain and update project timelines (MS Project/Jira) with a specific focus on documentation milestones. Track the status of deliverables to ensure they are completed prior to phase gates.
Cross-Functional Coordination: Act as the primary liaison within R&D with R&D Engineers, and Document Control process and coordinate across R&D with Quality, Regulatory, Cybersecurity, Product Management. Follow up with “strong personalities” to ensure technical content is provided and signatures are captured on time.
Process Compliance: Ensure all project documentation adheres to internal Design Controls (IEC 62304) and Product Development processes. Perform “pre-flight” reviews of documents to ensure they meet template standards before routing for formal approval.
Template Advocacy: Stay current on Quality template updates and proactively communicate changes to the engineering teams to prevent rework.
Education: BS degree in Business, Healthcare Administration, Engineering, or a related field required.
Experience: 2-4 years of experience in a project coordination or document control role, specifically within a regulated industry (Medical Device, Biotech, or Healthcare).
Regulatory Knowledge: Understanding of ISO 13485, IEC 62304, or GAMP 5 principles. Experience with Design History Files (DHF) is required.
Tools: Experience using document management systems (or similar PLM/QMS tools), Jira/Confluence, and Microsoft Project.
Influence Without Authority: Proven ability to “chase down” deliverables and hold senior-level engineers accountable for deadlines without being their direct manager.
Attention to Detail: Exceptional organizational skills; the ability to manage document touchpoints across a multi-component release.
Interpersonal Skills: A natural relationship-builder who is universally easy to work with, positive, resilient, and able to navigate diverse team personalities with grace and diplomacy.
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.
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.
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