
Manufacturing Engineer II at Boston Scientific
San Francisco Bay Area

Manufacturing Engineer II at Boston Scientific
San Francisco Bay Area
Mechanical engineer with experience in the medical device industry, both on the manufacturing side and the quality side. Direct experience with product and process validation, process optimization, product transfers, corrective and preventive actions, investigating product field failures, and solving "line down" situations.
Interested in transferring over to more of a design role (PD or R&D). I would be interested in staying in the medical device industry to accomplish this goal. However, my true passions lie on the environmental front; I would love to find a position in the renewable energy industry (solar, in particular), or designing for a bicycle company.
Process validation, process optimization (design of experiments), product transfer, corrective and preventive actions, root-cause analysis.
(Public Company; BSX; Medical Devices industry)
October 2008 — Present (1 year 2 months)
Manufacturing Engineer II
(Oct 2008 – Present))
Providing engineering support for the transfer of a high volume manufacturing line for a family of Class III Therapeutic Electrophysiology catheters, including:
• Training receiving site engineers on manufacturing process
• Reviewing/updating documentation related to work instructions, equipment, process validations, FMEAs, etc.
• Planning and execution of process validation (IQ/OQ/PQ/PPQ/TMV) activities.
(Public Company; 10,001 or more employees; BSX; Medical Devices industry)
February 2006 — January 2008 (2 years )
Provided quality support for several manufacturing lines to ensure that outgoing product conformed to corporate and regulatory requirements.
Investigated and remediated product and process non-conformances, including:
- Identification and quarantine of suspect product, including ship holds
- Root cause analysis of product failures
- Development of testing methods and acceptability criteria
- Implementation of system improvements to prevent repeat occurrences
- Leading meetings with other functional groups to discuss issues
Provided support for design changes and process improvements, including the determination of acceptable process capability and sampling plans, and statistical analysis of validation test results.
Investigated and reported on product field complaints. Developed work instructions for technicians to disassemble and test returned product for mechanical and electrical failures. Identified several previously unknown product failure modes.
(Public Company; 10,001 or more employees; BSX; Medical Devices industry)
March 2005 — February 2006 (1 year )
Worked with a team of engineers on a large-scale Process Validation Remediation project to thoroughly validate the manufacturing process for ten families of therapeutic and diagnostic Electrophysiology catheters.
Optimized process capability by utilizing Design of Experiments methods
Prepared validation testing protocols (IQ, OQ, PQ, and PPQ) and reports
Coordinated and executed of validation builds and testing
Developed manufacturing process instructions and trained operators
(Privately Held; 51-200 employees; Biotechnology industry)
July 2004 — March 2005 (9 months)
Performed testing and certification of laboratory safety equipment and HEPA filter systems for biotechnology, pharmaceutical, and medical device companies.
Performed troubleshooting and repair of various mechanical and electrical equipment.
Performed air handling calculations and adjustments.
Advised clients on possible system improvements.
(Educational Institution; 10,001 or more employees; Higher Education industry)
May 2001 — August 2004 (3 years 4 months)
Provided customer service to students, parents and staff, and assisted general manager of residential complex.
BSME , Mechanical Engineering , 2000 — 2004
GPA 3.4
bicycling, environmental design, renewable energies,
Kiwanis