Cyient
Website:
cyient.com
Job details:
The Key Responsibilities:
- Understand the project goals, scope, timelines and objectives in alignment with Program Manager/ Integral Project Manager
- Ensuring clear and consistent communication within the project team (Authors) and with stakeholders/Cross Functional Team (SMEs, H/W Engineer, S/W Engineer, Regulatory, Quality, Marketing, Clinical) to gather the inputs
- Establish the required deliverables from Program Manager and Cross Functional Team
- Create schedule for all Project deliverables
- Tracking for the project and respective deliverables
- Resource allocation for each project/deliverables
- Set up Daily Projects/deliverables tracking calls
- Communicating project status, progress, and issues to stakeholders
- Tracking of Windchill PLM deliverables and coordination with respective approvers to approve same in a timely manner
- Coordination with translation vendor to get translation deliverables timely with zero error
- Coordination with languages In country reviewer to get files correct files in a timely manner
- Tracking of error/defects, lesson learnt and document them for quality deliverables
- Projects deliverables folder management
- Tracking project progress against the plan and identifying potential issues
- Coordination with Windchill team
- Ensuring deliverables are kept in CCMS in structured way
- Responsible for process improvements
- Management of Audit deliverables
Competency:
- Project Management experience (Health Care Technology and Medical Device Documentation)
- Expertise in end to end documentation for New product development and life cycle management projects
- Knowledge of PLM (Windchill), Change Management (Change Request, Change Notice, Implementation Plan), Document Management, Part Management, BOM management and Configuration management
- Hands-on experience with Windchill
- Able to Support the team with technical product documentation
- Candidate needs to work with global customers and hence able to work in different time zone shifts
- Preferably experience within a Medical Domain (medical devices desirable, along with knowledge of FDA Quality System Regulations, EU-MDR, CE marking, China submission-NMPA and ISO 13485)
- Proficient in Microsoft Office applications (Excel, Word, PowerPoint)
- Experience in writing Instructions for Use (User Manuals, Online help, Quick Guides, Operating Notes, user Information Update) and Service Documentation in English
- XML driven authoring tools/Schema ST4
Education/Experience:
- Bachelors /master’s degree in engineering/medical technology
- 10+ years experience
Personal skills:
- Leadership and Team Management
- Customer focused and a quality-oriented mindset
- Assertive and meticulous: make sure that procedures and standards are duly followed
- Eager to learn and improve the way of working
- Effective Communication and stakeholder management
- Mentorship and Training
- Critical Thinking and Problem Solving
- Attention to Detail and Quality Assurance
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