Kal Oliai

Kal Oliai, MBA, MS EE 4404 Via De La Plaza
(714) 343 7568 kal_oliai@yahoo.com Yorba Linda, CA

Strategic, Innovative, Results-Driven Leader seeks a position as
Using Deep Expertise in New Product Development, Engineering Management, Technology Strategy & Technical Marketing of Medical Diagnostic Instrumentations in Molecular, Chemistry, and Cytology, Life Safety Products, Clinical Automation Systems, & Data Communication Devices from Concept to Production to Full Commercialization with In-Depth Knowledge of NPD, Design Control, Six Sigma, Process Control, CAPA, Manufacturing & Operation, Contract Manufacturing, System Engineering, FDA Audit/remediation, 510K Submission, GMP, ISO, Regulatory Requirements such as FDA, CE, and Quality Engineering & Quality Assurance including:

Directing Product/Program Development, Engineering & Commercialization across multiple geographies for Medical Devices, Diagnostics, Clinical Automation, Life Safety, and Respiratory Protection Products.
Building World Class Product Development, Engineering Teams, Reliability program, Design Control & Quality System, Project Management, Performing Technical Due Diligence (acquisition and Licensing) and negotiating Manufacturing & Technology Contracts, and Providing technical leadership to engineering organizations and partners across the US, Europe, and Asia.

Managing Operations, Strategic Planning, Product Development, R&D Improvement & Design Control, Overseeing Product Line Management, Launch & After Sales Support to Meet Business/Client Objectives.
Holding Full Accountability for: Scoping of Technical, Pre-Marketing & Customer Needs; Product Definition, Schedules, Critical Milestones, Resource Planning; Budgeting & Finance; Program Compliance with regulatory Agencies & Quality System Regulation; Securing Strategic Outsourcing Alliances with Partners in Asia & USA to cut Development Time & Budgets; Hiring, Mentoring Staff & Implementing Leadership Succession Planning and Change Management.

Hologic, Inc. 2012-Present
Hologic, Inc., is a global leader in the development, manufacturing, and supplier of automated molecular diagnostic, Cytology, surgical products, and medical imaging systems and services that are used primarily to diagnose human diseases.

Directing, leading, and executing all activities in Clinical Laboratory Automation, Pre-analytical Analyzers, Assays, and other full Automation efforts for Molecular Diagnostics and Cytology programs.
• Product Development – Accountable for directing and executing all aspects of the Laboratory Automation, Molecular Diagnostic instrumentation, and Assay development programs from inception through completion including clinical studies, FDA submission & approval, program & supplier management, commercialization, and post launch activities for fully automated Molecular and Cytology instrumentations and pre-analytical sample processing and SW management system.
◦ Have successfully launched and commercialized multiple products globally in the rage of $2M – $23M consist of Molecular Diagnostics & Cytology instrumentation, FDA Class III assays, fully integrated Pre-Analytical instrumentation, and Lab Manager system.
• Technical Program Management- Accountable for strategic and tactical planning, day-day activities, project execution, monitoring and control of key programs and projects including alliance managements. Responsible for directing and executing medium and large scale instrumentation, Class III assay and SW projects simultaneously ranging from $2M – $23M (over 12-36 months).
• Reshaped culture of overspending, missing milestones, and mismanaging resources – Established oversight & governance processes, performance-first and process-smart thinking ensuring accountability across all levels.
• Turned around legacy projects – Turned around projects that had missed key milestones by adding necessary infrastructure, institutionalized key processes, formulating long-term objectives and standards of performance and measurement metrics. Resulting in improvements in efficiency, project delivery, project predictability and budget control.
• Negotiated Manufacturing & Technology Contracts to $25M –Led all the activities related to identifying, evaluating technologies and manufacturing partners to completely outsource all manufacturing and selected non-core designs for the pre-analytical sample handling system, including HW and SW. Selected, evaluated and negotiated contracts ranging from $1M to $25M with manufacturing and technology partners in Europe and U.S.
• Process Improvements – Achieved over 30% time reduction for end of line testing of instruments on the production floor, designed and implemented Integrate processes as a core competency by establishing project management best practices, production processes, project deep-dive, educating, mentoring and coaching staff within the program in addition to suppliers and third party manufacturing partners.
• Value Engineering- Achieved Savings up to $4M annually, directed and managed value engineering activities with operation and contract manufacturing partners in reduction of material costs and streamlining of processes.
• Technology Road Map – Responsible for directing the planning, managing and executing SW, HW, and Reagent related technologies with particular focus on Clinical Lab Automation including the coordination of activities at multiple sites and involving multiple parties while providing leadership to the project teams.

Honeywell International, Inc. 2011-2012
Honeywell, Inc., is a global leader in Life Safety Products, Respiratory Protection, Gas and Flame Detection & Monitoring, SCBA systems and fall protection with presence in many countries across the globe.
Directed Hardware, Software, and System groups – Managed and led multiple cross site global Product Development groups and projects with annual budget of several million dollars. Directed planning, design, implementation, and deployment of Life Safety, Gas Detectors, and Respiratory products. Accountable & Responsible for coordination and oversight of all development projects and tasks; including resource management, budget, project prioritization and product life cycle management.
• Managed over 30 – Member Project Management, Eng. Leads & Engineers, with annual budget of $8M – Managed staff ranging from Project Managers to Engineering Leads to QA to multidisciplinary technical staff in the U.S., Canada, and India. Established and Implemented Design Control Processes guidelines & Procedures, Quality infrastructure, and structured Training, that resulted in increased Compliance, Productivity, Customer Satisfactions, Manufacturability, and Accountability for the entire site, addressing quality, reliability, manufacturing, and operation.
◦ Successfully launched multiple products in life safety and Gas and Flame Detection that had been mismanaged and delayed in the past due to many factors. First new releases of products for the site in a few years.
• Established culture of quality – Developed and implemented Quality system, Reliability program, System Engineering, project management discipline and technical training in accordance with NPD processes and ISO & FDA Quality Management Systems and Requirements procedures. Established and implemented CAPA system in accordance with ISO and put into practice necessary procedures and personnel for monitoring the process to ensure compliance with Quality System Regulations and Regulatory Agencies.
• Created a well-integrated and highly effective team across multiple geographies – Established development and design environment by creating Center of Excellence, optimizing talents, and cross functional partnership across multiple geographies with rigorous focus on product development processes, business and product innovation.
• Set Strategic direction for product development, Manufacturing, Operation, and Quality initiatives & Compliance – Created and established processes & procedures for the entire product life cycle to ensure an excellence end-to-end customer experience. Established a Gate Phase control process for new product introduction, sustaining engineering, and design change control.
• Managed Operation and Manufacturing initiatives – Developed and Implemented operational and manufacturing initiatives for final test, Continuous Process Improvement, Process Development & Validation, and Supplier Quality to address technical performance, first pass yield and financial objectives. Greatly improved first pass and subassembly yield by implementing manufacturing and quality control standards, method & procedures.
• OEM & Outsourcing partnership: Established manufacturing and design partnerships in excess of $10M in outsourcing noncore competencies enabling the business to focus on key business objectives.

Beckman Coulter, Inc. 2008-2011
Beckman Coulter, Inc., is a medical diagnostics, lab automation and life science company with a global presence, revenues of $3.5 billion and staffing of 12000+ employees across 4 major divisions in the U.S. and 2 divisions in Japan and Germany.
Directed Hardware, Software, System, Industrial Design & Rapid Prototyping Departments with Projects ranging to $20 M – Directed, Managed and led multiple Instrument and Systems Development Departments and projects including Assay development with budgets ranging from $100,000 to $20 M annually. Directed projects and technical strategy, day-to-day operations & Functional Management, product definition, timeline/budget and resource planning with full Accountability for projects from both business and technical dimensions. Ensured program compliance with FDA, CE, and ISO Quality System.
• Managed up to 50 -Member Project Management, Project Engineers & Technical Team – Managed over 50 staff ranging from Project Managers to Engineering Leads to multidisciplinary technical employees. Increased team performance, productivity and innovation by providing training on leadership, project management, and Design Control (Quality and Regulatory) initiative projects and related FDA subjects. Highly skilled in hiring and building world-class teams.
• FDA Remediation Projects- Accountable for remediating R&D assigned 483 observations identified during FDA inspections, managed and completed investigations, root cause analysis, gap analysis, and final reports. Remediated Risk management plans, xFMEAs, Verification and Validation, traceability matrix, and associated Design Input and Output files.
• FDA Audit Findings- Assisted in creating, updating quality processes, design control procedures, templates and training materials as the result of 483 observations and to comply with FDA requirements.
• Set Strategic Direction for Product Development & R&D Process Improvement – Defined product and project priorities based on market needs and customer experience. Set strategic and tactical planning and support for product development and product life cycle management. Oversaw development of R&D process improvement and design control processes to streamline systems and improve efficiency, productivity and compliance.
• Controlled $12M+ Annual Operating Budget – Ensured expenditures are in conformity with the budget and managed according to goals, objectives and priorities of the business center. Ensured effective and efficient resource allocation across all new, enhancement and current product projects based on business priorities.
• Negotiated Manufacturing & Technology Contracts to $12M – Selected, audited and negotiated contracts ranging from $500,000 to $12M with manufacturing and technology partners in Asia and USA. Deep negotiation skills and manufacturing knowledge has resulted in cumulative savings of at least $6M.
• Achieved HW Savings up to $1M Annually with $10M Savings in After Sales Cost – Directed, coordinated and managed technical, engineering, and operational activities in support of ongoing development projects from concept to production to full commercialization of new and enhanced automation products for Medical Diagnostics field. Multi-year project provided savings of $1M+ per year in HW cost and $10M in after sales cost.
• Achieved 60% Time & Budget Reductions Resulting in $3.5M Savings on 2 Key Projects – Provided direction, leadership and technical expertise for next generation Diagnostic instruments including all scoping and requirements such as evaluation of new technologies, development tools, budget, customer inputs, resources and utilization of outsourcing partnerships. Achieved 60% time and budget reductions resulting in savings of $3.5M annually on 2 key projects.
• Performed Technical Due Diligence for Acquisition Targets with Cost Ranging to $800M – Performed all technical due diligence for Beckman Coulter successful acquisition of Olympus Diagnostic division.

Beckman Coulter, Inc. continued … with experience from 1989-2008
Led Development and Life Cycle Management of Products Generating $500M Annually – Managed Engineering Dept and served as Core Team Lead for development of products from feasibility through launch, ramp-up and support of marketing and sales. Engaged customers regarding feature updates on current and next generation products. Provided guidance in strategies, design, development and application of new technologies. Developed US and Asian OEM partnerships to cut costs and improve quality.
• Controlled Budgets ranging from $14M to $23M – Consistently delivered projects within budget with full responsibility for resource allocation, product development, maintenance and other project related assignments from initial assessments to commercialization.
• Cut Development Time 50%+, After Sales Costs by 20% & Improved # of Service Calls 30% – Promoted strategic alliance with outsourcing vendors that improved competitiveness and cut development time by better than 50%. Managed after sales cost projects that reduced costs by at least 20% and improved # of service calls by 30%.
• Led Product Development Group & Platform Development Department – Directed Product Development Group in support and management of critical customers and sensitive accounts. Managed Platform Development Department in support of all development and line activities, budget and people development. Oversaw current product projects and legacy products achieving no major stop ship.
• Oversaw 8 Direct Reports and Extended Team of 45-50 Staff – Forecast staffing requirements, recruited and developed Project Managers, Project engineers and multi-discipline technical staff.

Led Development of Products Generating $400M to $500M Annually – Managed development of products from concept to feasibility to production to commercialization of latest General Chemistry instrument and two derivative product lines. Three instruments for three different markets were completed on time, on budget, and ahead of schedule with outstanding commercialization success contributing to company’s ongoing flagship product lines.
• Managed & Led 30+ Member Engineering Team – Managed Engineering Team in delivering on time, on budget of quality General Chemistry and Automation systems. Managed coordination and execution of build/integration/test/delivery of prototypes, Pre-Production (PPI) and Production instruments. Successfully launched three products that became Beckman Coulter’s flagship Chemistry analyzers and WorkCell, with 1000s of instruments currently placed all over the worlds.
• Design & Development – Oversaw system design and development including: Sample handling, refrigeration, motion control, photometric and colorimetric, hydro-pneumatic, ion selective electrodes, and power management.
• Product Line Management – Managed scoping from both technical, non-technical, pre-marketing and customer needs. Oversaw limited distribution of product lines to ensure smooth general commercialization release. Ensured compliance to all regulatory requirements such 510K, UL / Safety. Supported product line for entire year after commercialization to ensure after sales cost and service calls were within expectation set during feasibility.
• Extended Life of Existing Product Generating $250M to $300M Annually – Designed fully automated Sample Clot Detection System including hardware, motor controller boards and firmware to ensure sample pick up accuracy and increase customer satisfaction; project extended life of existing product generating $250M-$300M a year annually.

Analog & Digital Circuitry Design/Development – Designed and developed: Low noise analog and digital signal processing boards using photometry in visible / infrared spectrum for General Chemistry Analyzers. Signal condition boards and controller for LPIA system in infrared spectrum. Extremely low noise signal conditioning modules for ISE (Ion Selective Electrode) systems and Colorimetric system for detection of STAT chemistries. Fully closed loop stepper motor systems (1st in industry) for automated sample and reagent handling systems with accuracy of better than 0.5μL.

Novation, Inc & DCD, Inc 1985-1989
Designed and developed analog and digital circuits for data communication and devices from concept to production for Data Communication Systems and Telecommunication Industry. Other duties include designing semi-custom Gate-Array, low power switching power supplies for portable devices and Automatic Test Equipment for data communication products.

MBA – Azusa Pacific University, Azusa, California
M.S., EE – West Coast University, Los Angeles, California
B.S., EE – Weber State University, Ogden, Utah

  • Updated 8 years ago

To contact this candidate email kal_oliai@yahoo.com

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