Christopher R. Staub

• Own manufacturing engineering support for medical device production, maintaining 98.2% process stability and achieving 15% throughput improvement through targeted optimization initiatives.
• Develop and execute IQ/OQ/PQ validations for new product introductions, completing 8 validation packages in 2024 with 100% FDA and ISO 13485 compliance rate.
• Partner with R&D, Quality, and Supply Chain teams to resolve production issues, reducing defect rates by ~22% and cutting resolution time by 40% through structured root cause analysis and CAPA deployment.
• Author and maintain SOPs, work instructions, and equipment protocols to standardize execution and ensure audit readiness.
• Advance Lean and Six Sigma initiatives that improved yield by ~10%, reduced scrap costs by ~$65K annually, and cut operating costs by ~10% while scaling tooling and equipment capabilities.
• Coordinated cross-functional teams across Quality, Design, and Production to implement process improvements and validation activities, ensuring on-time completion of CAPA and CO actions.

• Designed and executed IQ/OQ/PQ strategies for manufacturing processes, equipment, and tooling to satisfy regulatory scrutiny.
• Identified waste and cost drivers, delivering targeted process optimizations that elevated yield and cycle efficiency.
• Led root cause investigations across cross-functional teams, driving corrective actions that prevented repeat quality events.
• Partnered with Quality on CAPA execution, reinforcing a culture of traceability, documentation accuracy, and continuous improvement.

• Delivered hands-on technical expertise that kept production lines running, troubleshooting complex issues alongside engineers.
• Performed preventive maintenance, calibration, and repairs to uphold equipment capability and regulatory compliance.
• Maintained meticulous manufacturing documentation and supported Lean/Six Sigma events to unlock productivity gains.

• Executed SOP-driven manufacturing activities while monitoring equipment performance and coordinating timely maintenance.
• Spearheaded continuous improvement opportunities that enhanced productivity and material utilization.
• Documented production records with precision and mentored junior technicians on quality and safety expectations.

• Interpreted FAA, EASA, and international regulations to lead compliance programs across an airline maintenance organization.
• Conducted internal audits, maintained controlled documentation, and stewarded Safety Management System initiatives.
• Facilitated regulator engagements, supported incident investigations, and drove preventive actions post-review.

• Conducted scheduled and unscheduled aircraft maintenance, inspections, and repairs in accordance with regulatory standards.
• Diagnosed system discrepancies using technical publications and instrumentation, executing repairs that restored airworthiness.
• Managed tooling and parts inventory to keep heavy maintenance projects on schedule.

Access Point Vascular (APV) — Mobile App Redevelopment

Side project with team peers • 2024 – Present

• Collaborating with cross-disciplinary teammates to transition APV’s legacy Angular mobile app to a modern React Native experience for nurse and manager users.
• Led complete rewrite from Angular → React Native (Expo SDK 52), refactoring authentication and navigation flows.
• Implemented secure AWS Cognito login and integrated REST API endpoints via AWS Lambda + PostgreSQL RDS.
• Introduced TypeScript across all modules, improving type safety, reliability, and maintainability.
• Set up GitHub Actions for CI/CD pipelines and automated Android build deployments.
• Achieved 100% React Native test coverage (74/74 tests passing) with comprehensive mocking system and optimized Jest configuration.
• Established TypeScript strict mode and comprehensive code quality standards with ESLint, Prettier, and Husky pre-commit hooks.

Tech Stack: React Native (Expo 52) • TypeScript • AWS Lambda • Cognito • PostgreSQL RDS • GitHub Actions

Outcome: Improved team velocity and reduced build friction through standardized code patterns and automated pipelines.