Sarang Shah
Engineering Leader | Medical Device Development
Professional Summary
Engineering leader with 14+ years of experience developing, commercializing, and sustaining FDA-regulated medical devices, including molecular diagnostics, hematology, and automated urinalysis platforms. Proven track record leading cross-functional engineering teams through product development, design transfer, verification, post-launch reliability improvements, lifecycle management, and global manufacturing support. Successfully contributed to multiple commercial product launches while driving quality, risk reduction, operational excellence, and customer-focused innovation.
Key Competencies
Professional Experience
Staff Engineer (Process) - R&D Molecular
- Engineering Lead responsible for sustaining engineering, post-launch product support, and continuous improvement of BD COR and legacy BD MAX Molecular Diagnostic platforms.
- Developed an enterprise Power BI dashboard integrating field performance data from 105 deployed BD MAX systems to improve troubleshooting efficiency.
- Spearheaded optimization efforts for the BD MAX Tuberculosis (MDR-TB) PCR assay, enhancing customer workflow and increasing PCR target sensitivity by 25%.
Staff Engineer - Design Transfer Team Manager
- Led cross-functional engineering activities supporting successful commercialization of five BD COR molecular diagnostic assays over a 3-year period.
- Improved design transfer process efficiency by 35% through an in-process materials tracking system.
- Directed engineering activities supporting global transfer of BD COR assay manufacturing from Baltimore to Quebec.
Staff Mechanical Engineer - R&D Hematology
- Core team member on Beckman's flagship product, DxH 900 Hematology Analyzer, maintaining over 90% on-time delivery.
- Led hardware development activities for a multidisciplinary engineering team, reducing development timelines by 30%.
- Improved customer workflow during DXH 900 development and obtained US patent for magnetic tubing holder.
Senior Mechanical Engineer - R&D Hematology
- Led engineering initiatives contributing to a 300% improvement in DxH 800 analyzer reliability, generating ~$2 million in annual service cost savings.
- Supported design and development of DxU Iris $850m/840m Automated Urinalysis Line of Products.
- Drove FDA 483 warning letter Remediation efforts for Chatsworth facility.
Education & Training
Master of Science
Mechanical Engineering
Florida International University
Design & Manufacturing
Bachelor of Science
Mechanical Engineering
Sardar Patel University
Certifications
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Design For Six Sigma Foundation
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PMP Training - Danaher Diagnostics
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Lean Kaizen Training
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Risk Management Specialist
Patents & Awards
Published Patent
Magnetic Tubing Holder
US-11596491-B2
Recognitions
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Outside-the-Box Thinking Award DS Innovation Fest (BD)
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STAR of Excellence Award Beckman Coulter
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Tuition Differential Scholarship Florida International Univ.