CHINTAN SHAH

• Delivered 8+ medical device programs (catheters, implantables, diagnostics) from design to manufacturing transfer.
• Drove cross-functional collaboration, cutting cycle times while ensuring ISO 13485 & FDA 21 CFR 820 compliance.
• Managed $10M+ in project budgets, meeting cost and timeline targets through proactive risk management.
• Strengthened risk processes, reducing schedule delays by 10% across multiple programs.
• Served as primary client liaison, resolving technical/program issues within 48 hours.
• Maintained DHFs, requirements, and test plans, ensuring 100% audit readiness.
• Supported business development, securing $5M in new contracts via scope, budget, and timeline planning.

• Managed a portfolio of biotechnology projects, meeting timelines, budgets, and quality standards.
• Led cross-functional teams of 12+ scientists, engineers, and technicians to drive project objectives.
• Developed project plans, defining scope, milestones, and deliverables while proactively mitigating risks.
• Oversaw biotechnology process optimization (molecular biology, cell culture, assay development), improving efficiency and reducing time to market.
• Ensured compliance with cGMP and ISO standards through robust quality systems and documentation.
• Managed external partnerships and vendors, negotiating contracts and ensuring on-time deliverables.
• Presented progress, challenges, and process improvement recommendations to senior leadership.
• Mentored junior team members, fostering continuous learning and innovation.
• Key Project – Biotage PhyPrep System: Led automation of plasmid purification (maxi, mega, giga scales) delivering endotoxin-free material; managed 12-member cross-functional team; improved efficiency and reliability of purification workflow.

• Developed and initiated projects, including managing costs, schedule and performance.
• Led cross functional teams for multiple projects.
• Identified plans and resources required to meet project goals and objectives by setting realistic timelines and project milestones.

Project 1: NanoRep | August, 2021

• Managing a team of engineers to develop the next generation repeater pipette
• Managed a team of 9 engineers to create a new No Touch off Dispense repeater.
• Https://www.mt.com/au/en/home/library/datasheets/rainin-pipettes/nano-rep-electronic-repeater-pipette-datasheet.html

Project 2: Rainin Robotic system LTS tips | October 2020

• Managed a team to develop Robotic system LTS tips for clients
• Managed a team of 6 core team members including engineers, molders and packaging specialists to create a new production line.
• Delivered the project on time and only utilized 80% of the budget.

• Drove new product introductions, resolving manufacturability issues and improving cost and efficiency.
• Managed pilot production through successful product launches, developing DFM/DFA and optimized assembly lines, BOMs, workflows, and work instructions.
• Led and mentored technical teams in product introduction engineering and project management best practices.
• Collaborated with integrators to design and implement automation equipment and fixtures.
• Key Projects:
  BioClean Ultra Tips (Nov 2019): Led team to design automated production line, improving efficiency and reducing lead time by 30%.
  RAMS – Rainin Automated Marking System (Jan 2020): Developed automated laser printing process, cutting plastic waste by 70% and processing time by 40%.
  Sentinel Face Shield Project (Mar 2020): Managed production team of 42, delivering 2M face shields in 14 weeks.

• Lead CAPA and 8D activities for product and process quality issues, ensuring all facets of CAPA activities are addressed including effectiveness.
• Define and maintain the Quality Management System procedures to ensure compliance to ISO 9001, ISO 13485 and ISO 14971 regulations.
• Partner with New Product Introduction teams to support successful component qualifications at suppliers.
• Lead in the development of FAT/SAT/IQ/OQ/PQ Protocols and Final Reports, ensuring successful validation qualification of equipment and process.
• Work with New Product Introduction teams to establish and maintain Control Plans, DFMEA and PFMEA.
• Lead auditor for the company. Also worked on ISO audits.

• Lead ISO 9001 recertification and successfully passed ISO audit.
• Assist in First Article inspection submission, tracking, and reporting to ensure critical deliverables are reviewed before engineering, pre-production and production release for Product manufacturing.
• Perform FMEA, Control Plan, and other quality related documentation.
• Utilizing the principles, methods and tools of Lean-Six Sigma identify areas for time and cost savings, lead improvement projects and implement solutions. Develop baselines and track over-all savings

• Perform Corrective Action and Preventive Action on recurring quality issues.
• Lead Supplier qualification and Audits.
• Preparation of Quality Control Procedures and plans.
• Manage Supplier “8-D” Corrective Action Program for timely closures & effective results.

• Specialization: Supply Chain Engineering
• GPA: 3.71