Engineering & Regulatory service provider working with global medical device
manufacturing. They partner with customers to support them for all aspects of medical device Product Development Life Cycle.
Provide Engineering Leadership for product development lifecycle of medical devices from Gap
Assessment, Design Control, Engineering Documentation, Process Validation (IQ, OQ, PQ, TMV, TMD)
to Acquisition Integration Projects. Must successfully manage the customer requirements, oversee all
aspects of projects, set deadlines, assign responsibilities, monitor and summarize the progress of
project, manage the deliverables and lead Team in US. Project Management responsibilities
include the coordination and completion of projects on time within budget and within scope and
thereafter present reports to upper management regarding project status.
• 15+ years experience in the Medical Device Industry with strong team management
• Experience in Remediation or Acquisition Integration Projects is preferred.
• Strong & Clear Communication, Presentation & Coordination Skills (Written & Oral)
• Customer Relationship Management with various customers and successfully complete
• Attention to detail with task prioritization capabilities (Tactical, Operational & Strategic)
• Working understanding of FDA, GMP and ISO 13485.
• Willingness to travel
• Bachelor – Engineering Degree or any Advanced Science Degree