Experience

maruho medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior R&D Quality Engineer

  • Jul 2021 - Present

• Mechanical Valudation Engineer

  • Sep 2020 - Jul 2021



Facet Technologies LLC

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Engineer

  • Jan 2020 - May 2020

  • Quality Engineering • Design Engineering • Medical device reliability testing (design, fixturing, programming) • CAD, computer aided design and drafting • Quality Engineering • Design Engineering • Medical device reliability testing (design, fixturing, programming) • CAD, computer aided design and drafting



AbSolutions Med, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Engineer

  • Apr 2019 - Dec 2019

  • Designed and developed abdominal closure system • Established and implemented an electronic quality management system (QMS) • Document management • Training • Regulatory compliance to: FDA Title 21 CFR part 820, ISO 13485, and ISO 14971 • Designed and developed abdominal closure system • Established and implemented an electronic quality management system (QMS) • Document management • Training • Regulatory compliance to: FDA Title 21 CFR part 820, ISO 13485, and ISO 14971

• Quality Engineer

  • Feb 2012 - Apr 2019

  • Developed product and process validations that are consistent with Facet Technologies’ quality system and compliant to FDA Title 21 CFR part 820, international standards (ISO 13485 and ISO 14971), and customer and end user requirements• Lead Quality Engineer- Validated multiple alternate lancet needle suppliers reducing the lancet manufacturing costs- Developed insulin pen needle product line - Developed components to an insulin delivery patch - Qualified lancet injection molding work-cells • Supplier Quality Engineering - Maintained successful relationships with supply, engineering, manufacturing, quality, and regulatory departments - Reported supplier performance and quality to management - Assisted in the development and implementation of supplier management programs- Conducted supplier audits and evaluations of quality systems and manufacturing processes domestically and internationally (South Korea) • Major contributor in establishing a healthcare supply retail distribution process into Facet Technologies’ quality system which included evaluating and improving on current systems and processes while adding necessary processes to support this new business • Performed product and process investigations which included determining corrective and preventive actions - Produced design, product, and process improvements- Created and implemented a complaint investigation methodology and associated documentation system• Experience in injection and compression molding Show less

• Associate R&D Engineer

  • Oct 2008 - Feb 2012

  • Designed and developed single and multi-use lancing devices and lancets• Researched and designed surgical instrumentation• Designed, fabricated, and programmed fixtures for medical device reliability testing• Designed and implemented design verification test protocols to ensure design integrity during manufacturing transitions/transfers • Participated in multiple product lines that transitioned proprietary lancing device assembly from US to China, resulting in significant cost reduction while maintaining product quality and original design specifications• Performed product investigations - the generated data drove several design changes that resulted in product improvements Show less



S Nelson & Associates

• United States
• Utilities
• 1 - 100 Employee

• CAD Technician

  • Dec 2006 - Oct 2008

  • Project management • Drafting • Project management • Drafting



Legacy Medical Center of Atlanta

• United States
• Medical Practices

• Biomedical Engineer

  • Jul 2005 - Mar 2006

  • Established and headed the Biomedical Engineering Department • Created Medical Equipment Management Plan meeting JCAHO requirements • Led and coordinated hospital-wide equipment acquisition projects including evaluation, negotiation, acquisition, and capital cost forecasting of medical equipment and service • Performed preventive maintenance, repair, and evaluation of medical equipment • Established and headed the Biomedical Engineering Department • Created Medical Equipment Management Plan meeting JCAHO requirements • Led and coordinated hospital-wide equipment acquisition projects including evaluation, negotiation, acquisition, and capital cost forecasting of medical equipment and service • Performed preventive maintenance, repair, and evaluation of medical equipment



Southwest Hospital and Medical Center

• United States
• Hospitals and Health Care

• Biomedical Engineer

  • Jan 2002 - Feb 2005

  • Headed the Biomedical Engineering Department • Directed rebuilding Biomedical Engineering Department in a hospital setting • Revised and updated the Medical Equipment Management Plan meeting so that it met JCAHO requirements • Led and coordinated hospital-wide equipment replacement projects including evaluation, negotiation, acquisition, and capital cost forecasting of medical equipment and service • Performed preventive maintenance, repair, and evaluation medical equipment • Served on Quality Committee and Safety Committee Show less



Stryker Endoscopy

• Hospitals and Health Care
• 1 - 100 Employee

• Design Engineer

  • Sep 2000 - Feb 2001

  • Researched and designed a tibial-fixation implant from surgeon’s concepts for soft-tissue ACL reconstruction and repair • Researched and designed instrumentation for cruciate ligament repair • Designed instrumentation to implant tibial-fixation device • Exposed to ACL reconstruction/repair surgical procedures • Researched and designed a tibial-fixation implant from surgeon’s concepts for soft-tissue ACL reconstruction and repair • Researched and designed instrumentation for cruciate ligament repair • Designed instrumentation to implant tibial-fixation device • Exposed to ACL reconstruction/repair surgical procedures