Ezra Miksic

About Ezra Miksic

An accomplished development and operations professional with 12+ years’ experience. MBA with a concentration in technology and risk management, Lean Six Sigma Black Belt certification. Expertise in lifescience and medical device instrumentation, process development, life cycle management and operations. An adaptive, detail oriented and conscientious professional with a diverse professional background and demonstrated ability to strategize and prioritize resources within budgetary and other constraints to accomplish multiple tasks while building and maintaining strong relationships with clients, customers and colleagues.Summary of Qualifications• Demonstrated proficiency in product development from inception to product launch and support.• Experience managing complex projects, engineering leadership and mentorship, leading cross site communications and collaborations. • Multi-disciplinary experience in electronics, software/firmware, electro-mechanical, fluidics, optics, experiment design, total quality management, statistics and data analysis.• Experience with Six Sigma projects, statistical process control, lean manufacturing and DFx.• Experience with total quality management and continuous improvement. • Experience in critical parameter management (CPM) and design of experiments (DoE).• Excellent communication skills to interface with vendors, outsourcing and contract manufacturers.• Working knowledge of ISO 13485, ISO 14971, cGMP, CE, CFR Title 21, 510k and other regulations.• Educated in strategic thinking, risk analysis, risk management and decision making.

Experience

1. Engineer, New Product Introduction

   Illumina

   Mar 2011 — Present · La Jolla, CA, US

   Interface between R&D and production to implement, evaluate and improve manufacturing methods, leverage expertise and knowledge of product design, apply statistical methods, improve production techniques and implement quality control standards. Interact with vendors, contract manufacturers both local and overseas to resolve production issues while ensuring performance requirements and quality standards are met. • Test champion, developed production test strategy in concert with key suppliers and contract manufacturers.• Create operations resourcing plans and schedule for new instrument projects.• Operations lead for xFMEA development of a next generation sequencing instrument.• Operations lead for transfer of a 510(k) diagnostic genotyping scanner to operations and manufacturing.• Led IEC 61010-1, IEC 61•••••01, EN 61326-1 testing and re-engineering for a genotyping scanner.• Led cross functional project teams to evaluate marketing, field service, manufacturing and statistical data to drive engineering and manufacturing activities for mature gene sequencer instruments. • Led engineering team to improve fluidics subsystem yield from 30% to >97% for a new sequencing product.• Led 8D investigation teams to solve instrument and production issues concerning fluid delivery systems. • Develop and implement mitigation plans in accordance with ISO14791, ISO13485 and other standards. • Develop controls and software test requirements, configuration management and backwards compatibility. • Authored and drove software user requirement specifications, usability testing, verifications and validations.• Managed overseas and cross site projects, successful product transfers and process implementations. • Assessed and balanced manufacturing requirements with R&D resource demands during prototyping, pilot and early production for efficient process and test development for in-instrument fluidics and diagnostic tools.

Education

• California Miramar University

  MBA, Technology Management

  2012 — 2014

• Georgia Institute of Technology

  ME, Electrical Engineering

  1999 — 2000

• Rensselaer Polytechnic Institute

  B.S, Computer Systems Engineering

  1995 — 1999

• UC San Diego

  M.S, Oceanography through the Applied Ocean Science department 2003

  2003 — 2005

Skills

• Validation
• Programming
• Documentation
• Microfluidics
• Automation
• Testing
• Labview
• Instrumentation
• Sigmaplot
• Design for Manufacturing
• Eagle
• Temporal Manipulation
• Cross-Functional Team Leadership
• Oceanography
• Design of Experiments
• Manufacturing
• R&D
• Solidworks
• Optics
• Electronics
• Orcad
• Matlab
• Medical Devices
• Product Lifecycle Management
• Microsoft Office
• Firmware
• Product Development
• Analysis
• Embedded Systems
• Assembly
• Biotechnology
• C++
• Problem Solving
• Operations Management
• Engineering
• Fiber Optics