Process Optimization Engineer

4 weeks ago


Reston, Virginia, United States Planet Pharma Full time

At Planet Pharma, we are seeking a highly skilled Process Optimization Engineer to join our team. As a key member of our organization, you will be responsible for overseeing and optimizing the Issues Triage and Investigation (ITI) processes, which direct our issues handling and failure investigation workflows.

This role will focus on improving process efficiency, enhancing communication between cross-functional teams, and ensuring that the process effectively facilitates the resolution of issues. You will work closely with teams such as Fleet Management, Quality, Operations, Reliability Testing, and Field Service to drive continuous improvements.

Key Responsibilities:

  • Process Development & Optimization: Design, implement, and continually refine the ITI processes and cross-functional communication. Identify bottlenecks, inefficiencies, and areas for improvement.
  • Issue Monitoring & Analysis: Monitor reported issues across various sources. Categorize issues, identify trends, and analyze underlying causes to proactively address emerging problems.
  • Stakeholder Collaboration: Act as a central point of contact for teams across the organization, ensuring that process updates are communicated effectively, and all stakeholders are aligned.
  • Performance Monitoring: Regularly track and analyze process performance metrics (e.g., throughput, resolution times, error rates) to measure the effectiveness of current processes and identify opportunities for enhancement.
  • Compliance & Risk Management: Ensure all processes are compliant with FDA regulations, quality standards, and internal policies.
  • Training & Support: Provide training and support to team members on process improvements and best practices. Ensure that all staff understand their roles within the process and the importance of adhering to standards.
  • Cross-Functional Leadership: Lead and facilitate cross-functional meetings to address process improvements, drive initiatives, and foster collaboration among teams.
  • Documentation & Reporting: Develop, maintain, and update process documentation to ensure clarity and consistency. Provide regular reports to senior management on process performance, key metrics, and any necessary adjustments.
  • Trending & Predictive Analysis: Utilize data from reported issues to establish trends, predict potential systematic problems, and work with teams to implement preventive measures.

Requirements:

Bachelor Degree/Master Degree in Biomedical Engineering, Computer Science, Electrical or Software Engineering.

Years' Experience Required:

Senior – Bachelor Degree (4 yrs), Master Degree (2 yrs)

Principal - Bachelor Degree (7 yrs), Master Degree (5 yrs)


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