Harry Etheart

Email: abqd00@r.postjobfree.com

Address: *** ******* ****

City: Shavertown

State: PA

Zip: 18708

Country: USA

Phone: 415-***-****

Skill Level: Management

Salary Range: $110,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

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Job History / Details:

HARRY ETHEART

Telephone: 415-***-****

Email: abqd00@r.postjobfree.com

PROFESIONAL EXPERIENCE:

Pride Mobility Products Corporation - Exeter, PA 18643

Manager of Products Integrity and Testing - From November 2004 to August 2012.

Managed all Pride Mobility regulatory compliance and products safety testing, using a combination of in-house testing and external third party testing. Supervised the company's products designed, tests, and documentations to satisfy the health and safety regulatory and standards requirements by provided design guidance and overseeing product compliance.

Capable of managed multiple projects and monitor regulatory process to ensure timely executions of compliance with company regulatory requirements globally. Formalized risk managements that identify scope impact of design and contribute to the building of corporation research developing regulatory systems and infrastructure needed for global compliances.

As a Technical Lead Auditor, developed testing validation plans and coordinating corrective actions for issues found during tests or in the field. Created strategy with design engineers and product managements during design reviews for mitigating risks prior to market by identified potential issues and provided manageable solutions.

Provided safety support throughout development phases by communicated regulatory standard requirements between various groups for effective resolution of potential safety and quality problems. Interfaced with regulatory agencies during inspections, supplier quality and regulatory technical and business issues. Responsible for supporting and answering questions from internal and external customers on regulatory, quality and safety issues for products and requirements approval process for FDA 21 CFR Part 820, FCC, EMC, UL, CSA, ASTM, OSHA, CPSC, CPSIA, EPA, ASTM, CCC, DEA, Prop65, WEEE, RoHS and REACH.

Managed regulatory activities by assessing, testing and mitigating emerging regulatory changes by provided recommendation measures to reduce or eliminate and identified hazard and juggling multiple priorities effectively and influenced others in order to meets regulatory compliances by interacting with internal and external partners as necessary to support efficient and effective product development. Responsible for technical data products submission approval, testing and mitigating of risks prior to market, usage of warning labels and, FDA investigators and/or Notified Body auditors review, significant interaction with product managers for regulatory dialogue for 510K submissions, company standards and policies to support ISO 14385, ISO 9000 and the creation of technical files and, design dossiers to support FDA, Low Voltage, EMC and Medical Devices Directives for CE Mark.

GLOBAL SEMICONDUCTOR SAFETY SERVICES (GS3) Intertek-ETL-Semko - Menlo Park, CA 94025

Product Safety Engineer - From January 2000 to November 2004.

Conducted multiple products safety/compliance assessments and tests to meet requirements of SEMI, NFPA, OSHA, IEC, EN, UL, CSA, CE Marking and, LVD, Machinery, EMC, RoHS Directives for potential of mechanical, electrical, EMI, chemical and environmental hazards. Performed product safety assessments to industry relevant standards by identify testing requirements for compliances. Tested multiple products in parallel/generated technical reports for safety, reliability and certification requirements.

Project consultants' and hands-on testing capability by providing technical assistance to various clients to eliminate EMI/RFI, LVD, Machinery Directives, SEMI, OSHA and NFPA product safety concerns. Provided regulatory consultation and testing result to clients for compliance during on-site type testing and factories auditing. Performed product FMEA, safety, and EMC testing, fire risks and hazard analyses for different types of manufacturing equipment including Laboratory equipment, Information Technology, Machinery heavy construction equipment and consumer goods home appliances.

TUV ESSEN / CETECOM - Mountain View, CA 95035

Site Manager/ Regulatory Engineer - From July 1997 to December 2000

Supervised and trained engineers, technicians and sales personnel in the field of Product Safety Requirements. Hands-on experiences in multidiscipline equipment safety testing, FCC, EMC. Products consultants, performed audits as Lead Auditor for factory inspections and client internal quality processes. Prepared technical reports and performed testing on electromechanical equipment to the requirements of TELECOM, SEMI, CB, UL, CSA, and Australian Standards. Managed product safety testing and certification services to a variety of industries include telecommunications, home appliances and commercial industrial products.

Project management and consulting for technical assistance to various clients to eliminated product safety concerns. Provided regulatory consultation to clients for compliance in respective to product safety areas, on-site testing and factories auditing. Performed product safety hazard analyses and testing for different types of manufacturing equipment by developing and implemented regulatory strategies for new and modified products.

TUV PRODUCT SERVICE - Research Triangle Park, NC and Danvers, MA

International Liaison Engineer - From June 1992 to June 1997

TUV Product Safety Engineer as a Liaison Engineer at a UL office. Conducted testing to verify product compliance for certification approval and, administered certification approval processes for GS, TV, CE mark and, CB scheme certification requirement.Responsible for procuring materials, equipment and other services, such as scheduling and tracking contractual services with third party labs. Conducted factory inspection per ISO 9001. Experience in design and EMC testing FCC (EMI emissions and immunity), CISPER and, fundamentals of electrical safety, laser safety, EN300.220 and pressurized gas safety.

CREDENCE SYSTEMS CORPORATION - Burlington, MA

Test Engineer - From September 1988 to June 1992

(Automatic Test Equipment and Mixed Signal Tester for Semiconductor Manufacturers)

Provided testing support to a team of mixed-signal group by timely completion of hardware and firmware applications and products validation testing. Created training manual SOP for testing of subassemblies. Supervised staff of five test technicians for maintaining production testing schedule and quality standards.

EDUCATION AND TRAINING:

Achieved Bachelor of Science in Electrical Engineering - BSEE - Northeastern University in Boston, MA.

Certified Biomedical Auditor (CBA) Training - ASQ - Boston, MA.

Using Warning and Instructions to Increase Safety and Decrease Liability Training - University of Wisconsin - Madison, WI.

Fire Investigation and Product Liability Litigation Training - University of Wisconsin - Madison, WI.

Risk Management and Analysis for Medical Devices Training - Oriel Stat a Matrix - Edison, NJ.

ISO 9000 Internal Auditor Training Course - QMR - Research Triangle Park, NC.

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