Engineer Electrical

ROLANDO MARTINEZ

**** ********** ***** *********: 727-***-****

Palm Harbor, Fla. 34683 Cell: 727-***-****

Email: abmuu8@r.postjobfree.com

SUMMARY

An electrical engineer with more than 15 years of Manufacturing Engineering and Quality Assurance

experience in the medical device manufacturing industry. Strong project management and interpersonal

skills used to mentor and guide high potentials. Develop, implement and maintain communication and

ideas between cross-functional groups for new product development. Knowledge of FDA Quality Systems

Regulations, IPC-610 and ISO 13485. Fully bilingual, English and Spanish.

PROFESSIONAL EXPERIENCE

Kaman Precision Products Inc.

Product Assurance Engineer (2010 – Present)

Responsible in both manufacturing and quality for production of a fuze delivered to Lockheed Martin.

• Coordinated production activities with Lockheed Martin (LMCO) (contractor) for on-time delivery of

fuze used in the Joint Air to Surface Standoff Missile (JASSM) system.

• Provided manufacturing and quality engineering support to the Integrated Product Team (IPT)

developed between Kaman and LMCO.

• Interpreted Lockheed Martin requirements into manufacturing work instructions. Worked with

production, test engineering, planning, and other support groups in revising and developing

manufacturing instructions and Bill of Materials for an electromechanical fuze.

• Provided daily support to production/assembly area. Revised and redesigned test fixtures and tooling

used for assembly.

• Developed new process flows when production used government or customer furnished material in

support IPT action items.

• Developed and worked with supplier quality on defining quality notes for use by suppliers and internal

Receiving/Inspection.

• Analyzed defect data, along with creating/dispositioning of NonConformance (NC) reports and

Corrective Action (CA) reports.

• Managed successful Lot Acceptance Test (LAT) of the JASSM Fuze with LMCO and Defense

Contractors Management Administration (DCMA) after product startup.

Baxter Healthcare Largo, Fla.

Principal Engineer (2003 – 2010)

Responsible for leading engineers, technicians, production personnel, supplier management and support

personnel in the introduction of new medical devices into manufacturing.

• Achieved project milestones by managing project schedules to meet manufacturing plant

commitments. Delivered production units ahead of schedule.

• Managed personnel work assignments (QA, Engineers, technicians, purchasing, etc.) associated

with bringing a new product on to the production floor.

• Developed and remained within project costing for instruments, fixtures, and equipment to be

used on the production floor.

• Served as Manufacturing Lead of the development group working directly with Product Design

Team on overall new product transfer to Baxter’s Product Development Process (PDP).

• Conducted/wrote validation and commissioning of processes and equipment used on the

manufacturing floor.

• Developed and updated Work Instructions, Bill of Materials (BOM) and process flows used for the

production build of medical devices.

• Managed changes to BOM and parts lists through internal document change control process.

Prepared and wrote changes for review board meetings.

• Worked with suppliers on providing parts and tools required for production. Prepared First Article

Inspections and receiving/inspection requirements.

• Lead cross functional team in problem resolution for new product introduction to achieve cost,

quality and delivery goals.

• Provided continuous improvements to existing product lines working with suppliers to reduce

product cost by 5%.

• Facilitated the creation of Process Failure Mode and Effects Analysis (PFMEAs) for new product

introduction between Manufacturing and Design Engineering. Mitigated all high level risks to

acceptable levels.

Sr. QC Engineer/Supervisor (1990 – 2003)

Wrote and performed process validations, providing closure to audit items and supervision of QC

inspectors.

• Developed Master Validation Plans for five (5) different medical device product areas. Supported

those product areas with writing process validations.

• Worked with the Tampa Improvement Plan Team in the closure of Corporate, FDA, TUV and

Internal audits. Responsible for investigation of audit items, along with writing status and closure

reports.

• Supervised 10 QC Inspectors, providing quality inspection support for the HemoDialysis

Instrument Production. Developed Inspection Plans used by quality inspectors.

• Maintained the Device History Files (DHFs) for the different product lines.

• Initiated performance of PFMEAs for product lines in support of validations.

• Worked with R&D and Manufacturing Engineering to accomplish the Safe-Launch of the Meridian

instrument.

• Provided support during TUV ISO facility audits.

• Provided QC reports to upper management including First Pass Yields (FPY) and Good

Documentation Practices (GDP) on Device History Records (DHR).

EDUCATION

BSEE, University of Miami, Coral Gables, Fla.

PROFESSIONAL DEVELOPMENT

• Trained in Lean Manufacturing, Baxter Learning

• Trained in Design for Six Sigma(DFSS), Baxter Learning

• Knowledge in IPC-610 and J-Std-100

•

SKILLS

• Word

• Excel

• Powerpoint

• Project

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