Project Manager Engineer

Responsibilities :

Lead end-to-end medical device product development projects. Manage project scope, timelines, budgets, risks, and resources. Coordinate with R&D, Design, Quality, Regulatory, Manufacturing, and Supply Chain teams. Drive project execution from concept through design, verification, validation, and product launch. Monitor project deliverables and ensure adherence to project milestones. Conduct project reviews, status reporting, and stakeholder communication. Manage design control activities, product changes, and lifecycle management processes. Identify and mitigate project risks and issues. Ensure compliance with ISO 13485, ISO 14971, FDA, and other applicable regulatory requirements. Support strategic planning, project governance, and continuous improvement initiatives. Mentor project teams and drive collaboration across functions.

Additional Responsibilities:

PMP Certification. Experience in Medical Devices, Healthcare Products, Diagnostic Devices, or Life Sciences industries. Knowledge of PLM tools such as Windchill, Teamcenter, Agile PLM, or similar platforms. Experience managing global or multi-site development teams. Strong leadership, communication, and stakeholder management skills.

Technical and Professional Requirements:

Medical Device Product Development Product Lifecycle Management (PLM) Program & Project Management Schedule, Budget & Scope Management PMP Certified Project Management New Product Development (NPD) Design Control & Change Management Risk Management (ISO 14971) Cross-functional Team Leadership Stakeholder & Vendor Management Resource Planning & Allocation Agile & Waterfall Methodologies Product Commercialization & Launch Regulatory Compliance (FDA, MDR, ISO 13485)