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Pay Range : $35- $40/hr on W2
Position Summary
We are seeking a highly organized and detail-oriented Project Coordinator to support engineering, product development, and change control activities within a regulated environment. This role will be responsible for coordinating project deliverables, tracking timelines, managing documentation, and supporting design and change control processes to ensure projects are completed on schedule and in compliance with quality system requirements.
The ideal candidate will have experience working with cross-functional teams, managing multiple stakeholders, and supporting engineering or product development projects within medical device, biotechnology, pharmaceutical, or other regulated industries.
Key Responsibilities
- Coordinate project activities, timelines, and deliverables across Engineering, Quality, Regulatory, Manufacturing, and other cross-functional teams.
- Drive on-time completion of documentation and project milestones in accordance with product development and design change processes.
- Initiate, track, and support change control activities, including Engineering Change Orders (ECOs), Engineering Change Requests (ECRs), and related documentation.
- Maintain and organize project documentation within Electronic Document Management Systems (EDMS) and Product Lifecycle Management (PLM) systems.
- Support design control activities including Design History File (DHF) documentation, design reviews, verification, validation, and design transfer documentation.
- Monitor project schedules, action items, risks, and deliverables, ensuring timely follow-up with stakeholders.
- Facilitate communication between engineers, scientists, quality, regulatory, manufacturing, suppliers, and external partners.
- Ensure documentation is complete, accurate, and compliant with quality system and regulatory requirements.
- Assist with process improvement initiatives related to project management, documentation, and change control processes.
- Prepare project status reports, meeting minutes, and management updates.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Business, Project Management, or a related field.
- 3+ years of project coordination, project management, engineering support, or product development experience.
- Experience coordinating multiple projects and stakeholders simultaneously.
- Experience using Electronic Document Management Systems (EDMS) or Product Lifecycle Management (PLM) tools.
- Strong organizational, documentation, and communication skills.
- Ability to work effectively with engineers, scientists, and cross-functional teams.
- Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
Preferred Qualifications
- Experience in medical device, biotechnology, pharmaceutical, diagnostics, or other regulated industries.
- Knowledge of Design Controls, Change Control, and Product Lifecycle Management processes.
- Familiarity with FDA regulations, ISO 13485, GMP, or Quality Management Systems (QMS).
- Experience with Veeva Vault, Windchill, Agile PLM, Arena, TrackWise, MasterControl, Teamcenter, or similar systems.
- Understanding of Agile project management methodologies.
- Experience supporting New Product Introduction (NPI), sustaining engineering, or product development projects.
Company Benefits include:Â Healthcare, Paid Sick leave & 401k
 If interested, kindly send us your update resume at hr@dawarconsulting.com/kavitha@dawarconsulting.comÂ
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