-1-
Board and Commission Application
Board or Commission you wish to serve on: Senior Citizens Commission
(Planning Commission applicants: Please attach supplemental questionnaire)
Submit application to:
Office of the City Clerk
3300 Capitol Avenue, Building A
P.O. Box 5006
Fremont, CA 94537-5006
Personal Information:
Mr. x
Mrs. ❑
Ms. ❑
Name: Lee Edwin K
Last First MI
Home Address:
Street City State Zip
Home Telephone: mobile Work Telephone:
E-mail: Fax:
Resident of the City of Fremont: 29+ years
Demographic Information:
Ethnicity:
□ American Indian or Alaskan Native X Chinese
□ Black or African American □ White
□ Afghan □ Vietnamese
□ Mexican □ Filipino
□ Indian □ Pakistani
□ Other Asian origin: ________________ (write-in optional) □ Other African origin: _______________ (write-in optional) □ Other Hispanic, Latino, or Spanish origin: __________ (write-in optional)
-2-
Gender:
X Male □ Prefer to self-identify
□ Female □ Prefer not to say
Language(s) Spoken: English
Background Information:
Why do you wish to serve as a member of this Board or Commission:
Being recently retired, I wish to spend more time serving my community and providing input in areas that may affect our city and its aging population.
What would you bring by way of perspective or experience to this Board or Commission:
Employment/Volunteer Information:
Please list any qualifications you feel would provide positive input to the work of the commission.
Organization: _______________________________________ Dates: ____________________
Location: ________________________________ Position(s): __________________________
Responsibilities/accomplishments:
See attached Resume highlighting various skills
Community Activities that you have been involved with (feel free to attach separate pages):
• Various volunteer activities supporting Fremont’s local Youth Basketball club, Mission San Jose High School Wrestling team, Cub Scout troop. • Volunteer Assistant Judo Instructor at local martial arts school teaching kids martial arts and self-confidence.
• Volunteer Meal Prep Lead for Abode Sunrise Village Shelter. Donated and prepared dinner meals for the shelter’s residents
Special awards or recognitions you have received: ________________________________
____________________________________________________________________________
____________________________________________________________________________
-3-
Education Information:
See Resume
____________________________________________________________________________ Educational Institution Degree/Diploma Field Year
____________________________________________________________________________ Educational Institution Degree/Diploma Field Year
Additional Information (Please provide any other information which you feel would be useful to the City Council in reviewing your application.)
I believe my executive management skills, owning and running a tech business, plus my various volunteer work serving Fremont would provide additional viewpoints to help our city prosper and well as represent our city’s senior citizens.
I recently became interested in this endeavor when I recently retired from the day to day workforce and was referred to this opportunity on the Commission by one of the current Senior Commissioner, Kath Fischer.
Civic service is a privilege and responsibility of interested, qualified, sincere citizens. The value and importance of wide participation of a large number of citizens cannot be measured. Your interest in serving on a board or commission of the City of Fremont is greatly appreciated.
General Information: Your application is a public document and will be kept on file for one year.
If you would like additional information, please call the City Clerk’s Office, at (510) 284-4060.
Please sign and date your application and submit to the Office of the City Clerk.
Thank you.
__________________________________________ 3/29/2023
Signature Date
Edwin Lee
v50
EDUCATION:
MS Quality Assurance
San Jose State University
San Jose, CA
BS Biology, Chemistry minor
University of Miami
Coral Gables, FL
AS Biology, Chemistry minor
Nassau Community College
Garden City, NY
• ASQ Certified Quality Engineer (CQE #14709) • IPC Certified J-STD-001 Trainer (CIT #J001-T1809004006) • IATCA/RAB sanctioned ISO 13485 Lead Assessor course certification (#LRF -10-12199)
PROFESSIONAL EXPERIENCE:
07/22 – Present RETIRED
11/21 – 07/22 Sr Director, Manufacturing Engineering
SEMLER SCIENTIFIC INC, SANTA CLARA, CA
A medical device company producing rapid point -of-care software-based non-invasive test sensors that measures arterial blood flow to aid in the diagnosis of peripheral arterial disease and to comprehensively evaluate patient s for risk of heart attacks and strokes. Provided operational structure and support for regulatory compliance and organization efficiencies. Integrated FDA IEC 62304/ISO 13485 regulatory requirements with the Agile software development process.
11/15 – 10/21 VP QA/RA / Owner, Managing Member / Project Manager SECOND SOURCE MEDICAL LLC, SAN JOSE, CA (acquired by MEDEOLOGIX, INC., 2022) A medical device contract manufacturing company offering client services for design, development, and manufacturing for commercially approved and non-approved medical devices that are in various phases of pre- and post-commercialization. Provide strategic regulatory, quality, production management, and business guidance for a diverse range of CE marked and Class I, II, & III medical devices used in orthopedics, opht halmic, diagnostic, vascular surgery, neurology, ENT, cardiology, and urological applications. Interface and project managed client’s production, quality, compliance, quality systems, and validations needs .
08/12 – 10/15 Director, QA
NEVRO CORP, MENLO PARK, CA
An active implantable medical device (AIMD) company producing devices and accessories for the novel application of high frequency (HF10) spinal cord stimulation to patients with chronic back & leg pain. Directed the company's supplier management, quality systems, and compliance programs . Responsible for supplier quality engineering staff, supplier qualifications onto the Approved Supplier List (ASL), supplier surveys and audits. Successfully prepared company and suppliers for FDA pre -approval commercial launch inspections (PAI) which included regulatory, audit management, quality systems preparation, auditee training, and FDA mock audits.
06/11 – 07/12 Sr. Director, RA QA
AVANTIS MEDICAL, SUNNYVALE, CA
A venture funded catheter based video imaging system medical device manufacturer for retrograde diagnostic viewing of the colon.
Responsible for regulatory compliance, all quality programs, document control, inspection, and quality compliance. Provide strategic quality & regulatory direction. Designed pro duct and process validation plans. Wrote company Physician Interaction Ethics handbook and instituted “Sunshine Act” law requirements. Regulatory and Quality Engineer product team contributor.
12/07 – 06/11 Director, QA QC
CARDIMA, INC, FREMONT, CA
Cardima is an electrophysiology device company manufacturing cardiac mapping and ablation catheters and related accessories for the treatment of cardiac arrhythmia. Oversaw departments that include responsibility for Product Quality Assurance, Qual ity Engineering, Product validations, Sterilization, Supplier Quality, Incoming & In -process Quality Control, Document Control, Quality Systems including compliance to ISO 13485, FDA, California FDB, and Japan PMDA QMS regulations. Interim department head for Regulatory Affairs, Manufacturing Operations, and Manufacturing Engineering. Managed regulatory product approvals for Japan (Shonin) and Thailand. Lead for FDA, CA FDB, Japan PMDA, and Notified body audits.
Edwin Lee
- 2 - v50
06/07 – 12/07 Sr Director, Quality Assurance/Regulatory Affairs
LAAX, INC, LIVERMORE, CA
LAAx is an early stage angel funded start-up incubator company developing technology in the cardiovascular arena. Developed, implemented, and maintained the QA system which includes product design controls for future due diligence review. Assisted with regulatory submissions.
08/05 – 06/07 Manager, Quality Assurance
BOSTON SCIENTIFIC CORPORATION, MOUNTAIN VIEW, CA
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices . Quality Assurance manager for the Mountain View plant. The Mountain View facility specializes in interventional catheter based vascular embolic protection systems.
Manage the site’s Corrective Action and Preventive Action (CAPA) System, internal audits, complaints & investigation system, manufacturing Quality Engineer support, Management Review, Incoming Quality Assurance, Supplier Quality Management & Engineering, corporate quality metric reporting & development, and regulatory compliance. Plant implementation manager for corporate wide quality system initiatives to mediate FDA issues. Site subject matter expert on various quality systems.
ADDITIONAL PROFESSIONAL EXPERIENCE:
CARDIMA, INC., FREMONT, CA - Director Quality Systems
VENTRICA, INC., FREMONT, CA - Sr. Director Quality Assurance/Regulatory Compliance EMBOL-X, MOUNTAIN VIEW, CA - Sr. Director, Regulatory Affairs/Quality Assurance LOCALMED INC., PALO ALTO, CA - Director, Quality Assurance/Regulatory Affairs JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS, RANCHO CORDOVA, CA - Manager, Quality Assurance NELLCOR, INC., HAYWARD, CA - Supervisor, QA Receiving Inspection COLLAGEN CORPORATION, PALO ALTO, CA - Supervisor, QA Supervisor/QA Systems CILCO INC., LESAGE, WV - Superintendent, Quality Control CORDIS CORPORATION, MIAMI LAKES, FL - Division QAE/ Supervisor, Division Assistant QC METAVAC INC., FLUSHING, NY - Senior QC
PROFESSIONAL CREDENTIALS:
• Managing Member / Partner (2007 - 2022). Second
Source Medical LLC , San Jose CA
(www.SecondSourceMed.com); Executive VP and
company managing business partner. Sold company
July 2022
• Notary Public, State of California (#2310230)
• Senior Member of American Society of Quality (ASQ)
• Member of Regulatory Affairs Professionals (RAB)
• Freelance C onsultant for Regulatory compliance, QMS
Audits, Quality Assurance, and Quality Systems
PUBLICATIONS, PRESENTATIONS:
• Lee, E., Chan, E., Minhas, B. (2005). Quadratic Model Predicts Lesion Outcome for the Cardima Cardiac Electrophysiology Radiofrequency Ablation System. Principle author. Poster presentation at the 27th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBS), Shanghai, China. September 4, 2005. • Guest speaker on Implementing SPC Training for the Chemical Processing Table-Top Convention, Concord, CA • ASQ's Effective Sampling Seminar instructor