Project Management & Execution
· Lead complex engineering projects from initiation through completion, ensuring alignment with quality, cost, and delivery goals.
· Manage project plans, scopes, timelines, and budgets, ensuring execution excellence at every step.
· Coordinate with vendors and review project documentation to ensure timely completion and compliance with specifications.
· Lead projects involving high-speed assembly and packaging of combination medical devices, including auto-injectors.
· Oversee design transfer and industrialization of drug delivery platforms, ensuring smooth scale-up to commercial production.
· Apply engineering best practices to optimize manufacturability, reliability, and regulatory compliance.
· Conduct risk assessments (e.g., FMEA, pFMEA) and lead process improvement initiatives across the product lifecycle.
· Serve as a mentor to Project Engineers I and II, contributing to a culture of growth and continuous improvement.
Client & Cross-Functional Collaboration
· Act as a technical subject matter expert with customers, regulatory stakeholders, and contractors.
· Collaborate with Quality, Validation, Manufacturing, and Business Development to ensure cross-functional success.
· Lead client-facing meetings, ensuring PCI’s engineering efforts align with evolving partner expectations.
· Contribute to engaging, transparent discussions during project planning and execution—your voice matters here.
Compliance & Process Optimization
· Ensure full compliance with all PCI policies and relevant regulations including 21 CFR Part 820, ISO 13485, ISO 11608, and ISO 14971.
· Lead efforts to implement corrective actions and troubleshoot technical issues.
· Utilize Lean Six Sigma and operational excellence methodologies to drive efficiency and quality.