The Key Responsibilities:
- Understand the project goals, scope, and objectives in alignment with Program Manager/ Integral Project Manager
- Ensuring clear and consistent communication within the project team and with stakeholders to gather the inputs
- Establish the required deliverables from CFT
- Work together with project manager to add and assign the right privileges for project team members in PLM system (Windchill), Time entry (Planisware) etc.
- Create schedule with Network Diagram for all DHF deliverables
- Create the resource and cost tracking for the project
- Monthly resource allocation report generation
- Milestone baseline creation and generate audit report
- Set up Daily Management boards and maintain
- Communicating project status, progress, and issues to stakeholders.
- You create and update the DHF in PLM system, support the teams with uploading documents, and make sure documentation is done according to templates and standards.
- You support the engineers on DMR activities in implementing Engineering Change Tasks, updating the configuration of products, and by maintaining the Technical Product Documentation in our product PLM system.
- Tracking project progress against the plan and identifying potential issues.
Compentency:
- PMP certification is preferred
- Project Management experience (Software Medical Device)
- Knowledge of PLM, Change Management, Document Management Part Management, BOM management, PDM Link, and Configuration Management
- Hands-on experience with Windchill object creation (CN/QR/Document/ etc.)
- Able to Support the team with technical product documentation to process a compliant Device History File (DHF) and Device Master Record (DMR)
- Candidate needs to work with global customers and hence able to work in shifts including night shift
- Preferably experience within a Medical Domain (medical devices desirable, along with knowledge of FDA Quality System Regulations, and ISO 13485)
- Proficient in Microsoft Office applications (Excel, Word, PowerPoint)
- Experience in writing instructions, manuals, and project status report in English
Education/Experience:
- Bachelors /master's degree in mechanical/software engineering or related engineering discipline
- 8+ years experience
Personal skills:
- Team player
- 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
- Experience in communicating with a diversity of stakeholders
