R&D Engineer

Description:

Title - R&D Engineer

Duration - 12 Months

Location - Santa Clara, CA 95054

Years

Experience:

3-6 yrs in a FDA regulated industry.

• Experience/familiar with supplier process validation and FDA regulations (ISO 9001 and 13485).
• Comprehensive knowledge of medical device design controls and Quality Management Systems.
• Experience with design and implementation of Project Development Plans including scope, scheduling, and resourcing.
• Lead Meetings with external suppliers and internal cross functional teams and Keep/distribute meeting notes capturing key discussion points/decisions made/action items.
• Drive teams to meet milestones and deliverables established in project planning and agreed upon with senior leadership.
• Recognize and integrate the broader implications of actions and proposals on the final project outcomes.
• Accountable for clearly defining and managing total project scope; develop and manage project charter and project plan to meet deliverables. Identify key milestones for project status reporting; complete projects on time and within budget constraints.
• Manage creation and updates of detailed project plans, resource and budget management, schedule management, project risk assessments, and project documentation.
• Lead cross-functional teams to execute projects, identifying tasks, creating and tracking project schedule with problem solving methodology; identify problems and work with cross-functional team to resolve them.
• Using advanced excel skills and Power
  
  BI, prepare and present data-informed written and oral reports and other presentations to sr. leadership audiences; under supervision, may create and deliver project review presentation to leadership as necessary.
• Track and present budget variances, and recommend contingency options.
• Create a work environment that supports team effectiveness.