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Program Manager
Ref No.: 18-21112
Location: Santa ANa, California
Position Type:Full Time/Contract
Experience Level: 10 Years
Start Date: 03/29/2018
 
Technical/Functional Skills
  • Experience in product development and engineering of complex hardware and software systems
  • Experience in Risk Management (ISO 14971) & Quality System Regulation (21 CFR 820)
  • PMI certification is preferred
 
Experience Required
  • Minimum 10 years of experience in product development with at least 5 years product development experience in medical devices
 
Roles & Responsibilities
  • Lead the quality remediation program (Creation/update of RMF, Creation/update of DHF Traceability matrix, Creation/update of HFE) with clearly established milestones
  • Work closely with TCS Onsite Team (Quality Engineers, Software Quality Engineer, Human Factors Engineer, System Engineers, Reliability Engineers) and Offshore (India) cross-functional team for delivery of gap report and remediated Design History Files (DHF), Risk management Files (RMF) and Human Factors Engineering Files (HFE)
  • Provide appropriate oversight and direction to quality engineering projects
  • Develop and maintain a detailed schedule for all quality remediation deliverables across multiple projects
  • Ensure that all deliverables across all projects are delivered on-time, within scope and within budget
  • Manage changes to the project scope, project schedule, resourcing and budget
  • Measure and report project status using appropriate tools, techniques and metrics
  • Report and escalate to management potential issues as needed
  • Proactively anticipate and identify risk areas and alert stakeholders
  • Attend project governance meeting
  • Conduct frequent formal and informal communication within the team to ensure full engagement and efficient operation
  • Effectively organize and motivate a highly skilled, cross functional team
Ensure compliance with FDA QSR, ISO 13485, ISO 14971, JJSV policies, and procedures
Generic Managerial Skills
  • Demonstrate strong and clear accountability for operational and program success
  • Motivate the team to achieve individual and program objectives
  • Demonstrate good judgment and timely decision-making
  • Foster the development of functional core team members to excel in their performance
  • Possesses the skills, knowledge and aptitude to engage, influence, and direct all functions involved in the development/maintenance of the assigned product
 
Education
  • BS degree in Systems Engineering, Mechanical Engineering, or Biomedical Engineering