Post Job Free

Resume

Sign in

Product Development Medical Device

Location:
Redwood City, CA
Posted:
June 20, 2017

Contact this candidate

Resume:

Kathy Brumett

**** ****** ******

Redwood City, CA 94061

Cell Phone : 650 670- 6273

Email: ac0xt9@r.postjobfree.com

OBJECTIVE

Associate Process Engineer Manufacturing Operations Product Development

Biomedical and Medical Device Companies.

Experience:

2012 -2016 : Family Obligation.

January 2012 – April 2012 OptiScan Biomedical Corporation Hayward CA

OptiScan Biomedical Corporation is a developer of a bedside Glucose monitoring System

For ICU patients that provides bedside continuous monitoring of patient’s glucose levels.

Every 15 minutes. It draws a small amount of blood converters the blood to plasma in micro

Centrifuge and is read by an infrared spectrometer. It manages patient at risk insulin over or under dosing. Aids in the help to provide patients stay in a healthy glycemic range.

Associate Process Engineer

Support Operations in the process of everyday activity.

Tracking issues and timelines.

Maintaining Equipment Manuals.

Calibrating and Tracking of Equipment.

Document Control Redlines and Revisions.

Supporting other Departments QA, R&D.

Working alongside Engineers to support products.

Operations Instructions Training.

GMP/GLP for all personnel.

Omnify Document Control Operating System

2008 - 2009 SAES GETTERS / Memry Corporation Menlo Park CA

Memry Corporation is the first company to have developed Shape Memory Materials.

Has developed Technology of Nitinol Devices. Nitinol tubes, Nitinol Components, Nitinol Wire.

This technology has also expanded to Electropolishing and Stent Manufacturing.

Associate Process Engineer

Support new product development.

Tracking process control issues.

Assisting Memry East on New development work.

Tracking & Training of all operators.

Working with the Senior Metallurgist.

Manufacturing Schedules.

Training Operators on Work Instruction.

Auditor Training / 5S weekly Audits.

DOE along with other Engineers.

Analytical testing.

Hazardous Material Responds

Maintaining Calibration Equipment.

Certified Auditor.

Safety Committee Member.

GMP /GLP for all personnel.

Maintaining Quality systems in place.

2001 – 2008 Conor Medsystems A Johnson & Johnson Company Menlo Park, CA

Conor Medsystems has developed a drug delivery stent for treatment of coronary artery restenosis.

The technology enables the delivery of multiple drugs or biotech compounds.

Senior Technician R & D (Startup Company)

The fifth person to be hired at this medical device company.

Supports new product development work with engineers to create working prototypes

Stent bench testing & fatigue testing. Catheter builds.

Electropolishing Process Development & Production.

GLP & GMP training of manufacturing personnel.

Catheter / Stent process development.

Scheduling Electropolishing jobs.

Lead role in training new hires.

Maintain quality systems, including pre-production quality assurance procedures.

Provide support in the resolution of product complaints, product problems or safety issues.

Develop and conduct laboratory testing protocols and document results.

Travleing to Athlone Ireland to setup Electropolishing process for Manufacturing.

Hydrophilic Coating process for Manufacturing .

Crosstrianing for Manufacturing operators for Hydrophilic operations.

Calibration Operations on all Manufacturing Equipment.

2000 - 2001 Aclara Biosciences Mountain View, CA

Aclara Biosciences develops microfluidics array technologies, referred to as a Lab on a Chip. The technology targets genomic applications RNA and DNA pharmaceutical drug screening.

Senior R & D Technician

Coordinate the production of electroforms by outside vendors once the mastering of the

design and specifications have been determined.

Assure delivery times and specifications are met by the vendors.

Responsible for QC of documentation.

Trained and supervised the technician’s prototyping the cards.

Prepare and prioritize all card Fab jobs into the queue and maintain inventory control.

Maintained clear communications between all departments.

Cleaning lamination of all cards using clean room procedures.

Kathy Brumett

1998 - 1999 Reflow, Inc. Menlo Park, CA

Reflow, Inc was a cardiovascular medical device start-up company that developed an ultrasonic catheter for total coronary artery occlusion and Restenosis. Company was sold to Fox Hollow Technologies.

Senior Technician/Supervisor (Startup Company)

First technician to be hired in this medical device start-up.

Excellent background in prototype development and quality testing of triple lumen,

ultrasound catheters and guide wires.

Self-starter with ability to multi-task and support all departments as needed.

Executed experiments on cardiovascular devices and analyzed the data.

Supported and attended animal studies.

Experienced in laboratory operations, vendor specifications, materials development /

biocompatibility, formulations, project support, field-testing and customer interface.

Material handling of all component parts.

Set up R&D calibration maintenance schedule.

Performed supplier audits.

Supervised all laboratory personnel technical training including GMP & GLP.

Assisted in the hiring of personnel and establishing policies and procedures.

1993 - 1998 Menlo Care A Johnson & Johnson Company Menlo Park, CA

Johnson & Johnson, Vascular Access Medical Division developed Peripheral IV catheters and a unique expandable hydrogel and various applications. The company was originally Menlo Care and Johnson & Johnson moved the operations to their East Coast facility following the acquisition.

Senior Technician R&D – Materials Development Department

Worked directly with the Director of Materials Development and Senior Polymer Chemist.

Executed experiments and analyzed data on medical peripheral IV catheters.

Research and development of experimental designs.

Managed and coordinated testing in the laboratory and established policies and procedures.

Performed extensive physical testing on Computer Controlled Analytical Instruments.

Biocompatibility testing, microbiological testing, drug load studies and toxicology testing.

Provided support to various departments in Operations, field products, and the Urological Unit.

Supported the extrusion department conducting research on polymer processes.

1987 – 1993 Raychem Corporation Menlo Park, CA

Technician - Materials Department

Responsible for routine experiments for Materials Product Development Laboratory.

Performed physical testing on adhesive and plastic products.

Verified and maintained MPI and SPI.

Organized and created new experiments with Senior Scientist.

Provided Manufacturing Support during trial runs.

SPECIAL TRAINING AND SKILLS

Quality Improvement, Design of Experiments, SPC (Statistical Process Control), Process Validation, Chemical Hygiene Safety, Cardiovascular Anatomy, Structure and Physiology, CPR Certification, Microsoft Word and Excel.



Contact this candidate