Manufacturing Engineer Manager Resume

PROFESSIONAL EXPERIENCE

Confidential

Manufacturing Engineer Manager

Responsibilities:

Managed a staff of 5 engineers and reported to the CTO & VP of Operation.
Member of team which implemented a ERP system to replace use of QuickBooks, MS Excel & MS Access.
Generated and maintained BOM's and routing’s (build times, yield loss for each sub/final assembly).
Collected yield loss data using customized defect codes.
Established standard costs of all devices (20+) and used to forecast commercialization ramp up.
Initiated a Lean Six Sigma training program with financial assistance from a Mass. Workforce Training Grant
Generated mfg. metric reports including output, yield, scrap pareto chart, utilization with the use of pivot tables.
Updated SOP's to ensure compliance with regulations, better define processes and provide flexibility as needed.
Implemented a defined yet flexible process of how jobs are processed and documented on LHR's. This provided full lot traceability and defined how unique situations are handled without shutting down production to process NCR’s.
Revamped the training system with a multi - tier competence training process. Closed CAPA which was open for years.
Updated risk assessment documents to close action items after process improvements were implemented.
Initiated generation of pFMEA’s (previously managed with Master Validation Plan documentation).
Purchased and installed a new air compressor and pressure monitoring system.
Implemented a temperature and humidity monitoring system eliminating manual monitoring.
Reconfigured the manufacturing floor lay out to optimize work flow. Added compressed air and electrical lines.
Worked with vendors to resolve quality issues and established second sourcing of critical components.

Confidential

Principle Catheter Mfg Engineer / Production Manager

Responsibilities:

Managed Mfg. staff of 1 engineer, 1 mfg. tech., 2 group leaders & 14 catheter mfg. assemblers.
Set up a mfg. metric system to collect and trend yield and production output by work station (200 defect codes).
Implemented process improvements, eliminated bottle necks & non-value added activity and balanced work flow at all workstations utilizing six sigma/kaizen/lean methodologies.
Outsourced packaging to allow for efficient mfg. scale up and to focus on core competencies.
Developed a $500K/yr sustaining engineering and $2M/yr mfg. budget. Successfully kept spending within budget.
Performed annual risk analysis and updated pFMEA's as needed..
Addressed and reduced customer complaints by implementing numerous design & process changes.
Improved durability of IVUS functionality by implementing a more robust electrical connection and implementing improved manufacturing testing and controls.
Developed and implemented improved fiber optical testing and in-process controls to verify functionality.
Managed FG inventory levels achieving goal of no back orders and no expired product.
Implemented Kanban material supply system within the clean room to ensure no shortage of supplies or components.
Managed introductions of design and process changes into production.
Ensured DFM was a priority for design changes which occurred approximately every 6 months.
Coordinated IQ/OQ/PQ's & design/process validations utilizing DOE's, gage R&R's, capability studies and other statistical analysis methodologies.
Resolved supplier quality related issues and worked closely with them to improve their manufacturing process.

Confidential

Manager, Manufacturing Operations

Responsibilities:

Managed production staff of 27 people including 3 direct reports.
Redefined production yields metrics (yield calculations and acceptance criteria).
Addressed multiple FDA 483 observations to improve process control deficiencies:
Validation of a steam sterilization data acquisition system and operator qualification process.
Initiated a new formulation process utilizing a tank with integrated spray ball and mixer as well as a pumping system and formulation scale to improve
Scheduled and coordinated process re-validation and equipment calibration and PM's.
Coordinated facility repairs and upgrades.

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