PROFESSIONAL EXPERIENCE

Confidential

Senior Mechanical R&D Engineer

Responsibilities:

• Write protocols and reports in order to validate supplier laser welding processes.
• Review Essential Requirements Checklist to ensure compliance with the new MDR.
• Modified implant packaging to use a lower cost material resulting in a 40% cost savings.
• Implement ECO changes to ensure documentation meets QMS requirements.
• Design instruments per inputs from Surgeons using SolidWorks.
• Perform instrument validations to ensure product performs as intended.
• Manage testing of implants through the transportation simulation validation process.
• Investigate and document responses to complaints received from field to satisfy FDA requirements.
• Work with existing suppliers to improve quality and seek out new suppliers for diversity.
• Write adoptions for new instruments to ensure sterility, cleaning processes, and materials biocompatibility are met.

Confidential

Senior Supplier Quality Engineer

Responsibilities:

• Developed and coordinate testing for new product verifications.
• Supported quality design assurance activities for product development projects.
• Led teams to drive to root cause for issues that develop during manufacturing of medical products.
• Audited Suppliers on a yearly basis to ensure they meet ISO 13485.
• Led teams to select and implement second source suppliers for critical components.
• Wrote IQ/OQ/PQ documents, protocols and reports, for internal and supplier processes.
• Published qualification reports of critical components in order to qualify suppliers.
• Managed new products through the design transfer process.
• Participated in Lean Six Sigma Black Belt teams to improve processes.
• Performed internal audits on a quarterly basis to drive improvement in Quality system and ensure compliance.
• Hosted weekly meetings with suppliers to ensure open items are driven to closure.
• Developed Supplier Scorecard in order to communicate with suppliers their status based on delivery, cost, and quality.
• Worked with core teams on Risk management activities including supporting and leading FMEA/Risk Management activities.

Confidential

Senior Quality Systems Engineer

Responsibilities:

• Wrote IQ, OQ, PQ validation protocols for new processes and equipment. Performed validations and published validation reports for the pedicle screw assembly process.
• Wrote substantial equivalency documents for new class II Sequoia MIS orthopedic instruments to demonstrate that the new product was as safe and effective as the
• Pathfinder instruments by comparing materials, intended use, mechanical properties, and change in risk for 510K submissions.
• Participated in 510K FDA submission teams, provided post surveillance data for similar products.
• Led external suppliers in the development of validated processes and equipment.
• Created Cognos reports to ensure that compliance was met on complaint parts being received back from distribution agencies. Reports reduced workload of compliance requirements by 90%.
• Performed complaint investigations to determine root cause of instrument and implant alleged deficiencies for spinal fixation/fusion product.
• Used statistical methods during investigations to determine quality trends that may require further action such as Risk Evaluations and CAPA investigations.
• Worked on cross - functional design teams to integrate post surveillance product information into new products.
• Used FMEA to analyze new and existing products to determine potential failure modes and their affects, especially failure modes that could cause injury or death.
• Participated in cross-functional CAPA teams to perform root cause analysis of alleged deficiencies.
• Participated in Risk Evaluation teams to determine overall health risk of instrument and implant complaint events.
• Submitted Medical Device Reports to the FDA for reportable complaint events.
• Mined and presented past complaint event data for 510K product applications to FDA.

Confidential

Senior Quality Engineer

Responsibilities:

• Worked on Infinity QS implementation team to integrate IQS software to allow for real-time statistical process control of pacemaker manufacturing processes.
• Supported circuit board manufacturing and resolved quality issues encountered on a daily basis.
• Headed Lean Six Sigma project teams to increase quality, reduce product cost and increase manufacturing efficiency.
• Created FMEAs for product and processes to determine potential failure modes.
• Employed design of experiments methodology to increase quality levels in the manufacturing processes.
• Analyzed and resolved all compliance issues in manufacturing of pacemaker/defibrillator circuit boards.
• Performed peer reviews with manufacturing in order to resolve quality concerns.
• Implemented Infinity QS process control system which reduced entry and analysis of control charts by 40%.

Confidential

Senior R&D Mechanical Engineer

Responsibilities:

• Participated in team to incorporate Master Control software into the R&D processes for Capacitor manufacturing. Successfully brought manufacturing and documentation control module online.
• Wrote visual basic for databases in Access that allowed manufacturing to collect data on processes still in development. Wrote PQ protocol and performed PQ on software to ensure validation.
• Developed new processes and equipment for high voltage capacitor manufacturing.
• Wrote IQ, OQ, PQ protocols for new processes and equipment.
• Designed and implemented new capacitor foil pick head that increased new capacitor product yield from 1% to 99%
• Coordinated external vendor activities to adapt existing laser interferometer leak tester to Guidant capacitor product.
• Optical leak tester tested ten times more products with 5 time’s higher accuracy than existing leak test technologies.
• Coordinated vendor activities to replace existing filling technology used in capacitor manufacturing. Developed equipment that eliminated 99% of electrolyte waste, reduced cleaning of capacitor product by 80%, and reduced cycle time by 20%.

Confidential

Senior Manufacturing Engineer

Responsibilities:

• Coordination of design to external vendor builds.
• Creation and scheduling of training required for operators in Mexico.
• Purchase and transfer of required tooling for manufacturing operations.
• Project managed team to reduce automated machine placement equipment setup reduction. Setup reduction effort resulted in a 600% reduction in setup time.
• Implemented prototype surface mount technology line which enabled prototypes to be built in 80% less time than outside suppliers.
• Designed product and fixtures using SolidWorks.
• Developed processes for new products, eliminated need for outside manufacturing needs

Confidential

Manufacturing Engineer

Responsibilities:

• Project manager in the implementation of Computer Integrated Manufacturing Software. Worked with vendor to develop modules that allowed assembly equipment to have programming directly created from circuit board GERBER drawings.
• Programming time required for automated equipment reduced from 3 hours to 8 minutes per circuit board.
• Supported the manufacture of new products resulting in 20% quicker lead times than externally built product.
• Developed and maintained all manufacturing processes in the PCB area - SMT Placement, Reflow, Wave Soldering, Secondary Processes, Hand Soldering, and Hot Gas Rework Stations.
• Supported the manufacture of new products and prototypes resulting in 20% quicker lead times than externally built product.
• Developed and maintained all manufacturing processes in the PCB area - SMT Placement, Reflow, Wave Soldering, Secondary Processes, Hand Soldering, and Hot Gas Rework Stations.
• Implemented statistical process control into S.M.T. line processes, screen printing, component placement, and reflow. Manufacturing defects in production were reduced by 50%