This document is a resume for Emmanuel AjaWara, an engineering manager with experience developing medical devices. It summarizes his expertise in areas such as design control, requirements development, product risk management, and regulatory submissions for medical devices. The resume details his professional experience managing projects and teams at Roche Diagnostics and Beckman Coulter, and highlights accomplishments such as improving product reliability and reducing development costs. It also lists his education in electrical engineering, industrial engineering, and software engineering, as well as relevant training and certificates.

1. EMMANUEL AJAWARA (510) 962-1102 eajawara@pacbell.net Page 1
EMMANUEL C. AJAWARA
(510) 962-1102
eajawara@pacbell.net
HIGHLIGHTS
Strategic and results driven Engineering Manager with expertise in development of medical devices
and biomedical systems. Dynamic Engineer with proven results in increasing testing efficacy. Effective
leader capable of simultaneously managing multiple projects.
Demonstrated expertise in:
• Development of medical devices in cross-functional and global teams
• Design Control, Design Change Request and associated deliverables
• Feasibility analysis and reporting
• Product/System requirements development and management
• Configuration management
• Product Risk Management for medical devices
• Design verification and validation of medical devices
• Product reliability analysis, testing and management
• OEM product verification and validation
• Medical device and biomedical product development
• Development in 21CFR820, ISO13485 and ISO14971 environments
• Development and management of system regulatory submission (PMA and 510k) documents
• Creation and management of PMA, 510k and Health Canada submissions
• Subject matter expertise in responding to FDA PMA and 510k submission questions
PROFESSIONAL EXPERIENCE
ROCHE DIAGNOSTICS, Pleasanton, CA
Leading manufacturer of medical devices for blood screening, virology, women health (HPV &
CT/NG), genomics & oncology, and microbiology.
Principal Systems Engineer II (Managerial) 2008-2015
Effectively managed areas of system development across several Roche Diagnostics product lines
with the following specific accomplishments:
• Managed creation of Systems Engineering deliverables including System Development Plans
and Reports, Requirements Management Plans and Reports, Product Requirements,
Configuration Management Plans and Reports, Risk Management Plans, Reports and Files,
Product Master Validation Plans and Reports, Verification Plans and Reports.
• Led System Development of several projects.
• Managed reporting, tracking and resolution of cobas 4800 System reliability which resulted in
record 98% system reliability prior to product release.
• Managed creation and on-time completion of cobas 4800 System design control output
deliverables.
• Managed system section architecture, creation and on-time delivery of cobas 4800 HPV
successful FDA PMA.
• Served as subject matter expert in responding to FDA’s questions on products under review.
• Created cobas KRAS Mutation Test System description for Health Canada submission.
• Led several cross-functional and global Product Risk Management Teams for medical
devices.
• Collaborated in cross-functional and global review/revision of risk management SOPs.

2. EMMANUEL AJAWARA (510) 962-1102 eajawara@pacbell.net Page 2
BECKMAN COULTER, INC., Palo Alto, CA
Leading manufacturer of biomedical and bioresearch testing instrument systems, tests and supplies
that simplify and automate laboratory processes. Company reported 2007 annual sales of $2.76B.
Staff Systems Engineer (Product/Process Leader) 2003-2008
Staff Engineer (Product/Process Leader) 2000-2003
Technical lead - Responsible for leading systems engineering activities in development projects with
$1M to $6M in budget. Directed system design with development and management of system
requirements. Assured product met / exceeded customer expectations through system verification and
validation to requirements. Severally achieved outstanding performance with the following specific
accomplishments:
• Demonstrated expertise in creating effective product requirements.
• Synthesized customer requirements into product specifications resulting in completion of a
development project one month ahead of schedule with 80% reduction in final product’s
standard cost.
• Managed a software development project, resulting in on-time completion and reducing costs
by 35%, creating a savings of $.5M.
• Led on-time department formation, training and mentoring of Systems Engineers.
• Simultaneously developed multiple products that met or exceeded requirements within the
development schedule and budget resulting in accolade from upper management.
• Optimized design verification with resulting test time reduction of 46%.
Principal Quality/Reliability Engineer 1992-2000
Coordinated with cross-functional development teams and synthesized customer needs or product
usage into requirements for new products. Planned and managed new product evaluations and
reliability testing. Severally achieved outstanding performance with the following specific
accomplishments:
• Effectively executed design quality assurance functions in numerous product development
teams. These functions included assuring compliance to design control requirements, product
risk management, failure analysis, design transfer to manufacturing and Senior Management
Product Release meetings.
• Planned and implemented product reliability programs, resulting in lowest product line
warranty and installation cost of 2.3% (vs. Company Average: 4.2%).
• Developed and integrated reliability programs into new product development process resulting
in ISO 9001 compliance and registration.
• Created and implemented a product testing procedure resulting in reduction of time by 35%.
EDUCATION / PROFESSIONAL DEVELOPMENT
SANTA CLARA UNIVERSITY, Santa Clara, CA
Master of Science (Electrical Engineering)
SAN JOSE STATE UNIVERSITY, San Jose, CA
Bachelor & Master of Science (Industrial and Systems Engineering)
UNIVERSITY OF CALIFORNIA, Santa Cruz, CA
Certificate in Software Engineering
NOBLITT & RUELAND, Irvine, CA
Certificates in CE Mark, FDA/ISO Design Control, FDA/ISO Software Requirements, Risk &
Hazard Analysis, Software Verification & Validation
ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)
Certificate in Design Control – Requirements and Industry Practice