Project Manager Engineer

Position Overview:

• We are seeking a skilled Project Manager Engineer with 7 to 10 years of expertise in Medical Device Product Development and Lifecycle Management.
• The successful candidate will oversee cross-functional product development initiatives, managing project timelines, budgets, and resources to ensure the effective delivery of cutting-edge medical device products while adhering to quality and regulatory standards.

Primary Duties:

• Direct comprehensive medical device product development projects from inception to completion.
• Oversee project scope, timelines, budgets, risks, and resource allocation.
• Collaborate with Research & Development, Design, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Steer project execution from the conceptual phase through design verification, validation, and product launch.
• Track project deliverables and ensure compliance with established project milestones.
• Facilitate project reviews, status updates, and communication with stakeholders.
• Oversee design control activities, product modifications, and lifecycle management processes.
• Recognize and address project risks and challenges proactively.
• Ensure compliance with ISO 13485, ISO 14971, FDA, and other relevant regulatory standards.
• Assist in strategic planning, project governance, and continuous improvement efforts.
• Guide project teams and foster collaboration across various functions.

Technical Qualifications:

• Expertise in Medical Device Product Development
• Proficient in Product Lifecycle Management (PLM)
• Experienced in Program and Project Management
• Skilled in Schedule, Budget, and Scope Management
• PMP Certified in Project Management
• Knowledgeable in New Product Development (NPD)
• Experienced in Design Control and Change Management
• Proficient in Risk Management (ISO 14971)
• Effective in Cross-functional Team Leadership
• Adept at Stakeholder and Vendor Management
• Competent in Resource Planning and Allocation
• Familiar with Agile and Waterfall Methodologies
• Experienced in Product Commercialization and Launch
• Knowledgeable about Regulatory Compliance (FDA, MDR, ISO 13485)

Additional Qualifications:

• PMP Certification required
• Experience in Medical Devices, Healthcare Products, Diagnostic Devices, or Life Sciences sectors
• Familiarity with 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 capabilities

Desired Skills:

Domain->Product Development->Product Lifecycle Management,Foundational->Program Management->Program Management,Technology->Embedded Software->Medical Devices