Broomfield, Colorado, United States
Primary responsibilities – Development and maintenance of safety certifications for Plasma Power products and components. · Develop and maintain product safety files to achieve CSA certification marking. · Liasson with CSA, a nationally recognized test laboratory, to complete new safety files submissions and update existing files as necessary. · Execute and document product safety testing as necessary to support CSA file submissions. · Create and maintain Safety/EMC Declarations of Conformity for power supplies and related products. · Research and obtain proof of compliance for safety related components used in AE products. · Update internal systems, such as iPro, and tracking tools with current product and component safety certification data.
Primary responsibilities – Regulatory compliance (including safety, emc, rf, chemical, etc.) and product sustaining for Water Pik and Church & Dwight electronic products. • Implemented a process to generate compliance technical files such as RoHS, REACH, PFAS, etc. including contracting a third-party data collection agency. • SME / Regulatory Lead for interpreting applicable regulatory and certification standards, laws, directives for new product developments and existing product families. • Responsible for confirming validity and completeness of all regulatory documentation including Declaration of Conformity (DoC), test reports, certifications, authorizations, etc. • Regulatory Compliance Point of Contact (POC) interfacing with global vendors, local and global teams, test labs and regulatory authorities focused on safety, emc, environmental and green requirements. • Verified regulatory requirements for product and packaging labeling including graphics, logos, text and translations. • Assisted logistics team with determining international country codes, tariff codes, instruction manuals, inserts, warning and caution labeling. • Led sustaining effort for electronic components including interfacing with design engineers, contract manufacturers and component suppliers to find, evaluate, select and implement alternate components into production.
Primary responsibilities – Regulatory compliance, prototype development, V&V creation and execution, manufacturing transition and product sustaining for medical products. • Co-developed a new service offering that evaluates lifecycle, RoHS and REACh compliance for components of product designs. • Assisted project management in the development of proposals to ensure accurate technical, budgetary, and schedule content. • Worked with customers to develop product requirements and agency test concepts to ensure products meets all relevant regulatory requirements. • Directed the development and assembly of prototypes by providing documentation and technical assistance to design engineering staff, material procurement team, and others as necessary to ensure high quality prototypes are built in a timely manner. • Developed, maintained and executed design verification, environmental and reliability test plans, traceability matrices, procedures, equipment, results, and other related documents to ensure product consistently meet high quality standards and agency requirements. • Scheduled and coordinated design verification testing, including agency submittals, off-site testing, and communicate status to the development team in a timely manner to ensure adherence to schedule and budget. • Transitioned products to manufacturing by providing documentation and assistance to ensure production start-up issues are resolved in a timely manner. • Provided sustaining engineering support to the manufacturing team through detailed failure analysis, test support, alternate component recommendations, documentation revisions, assembly support, obsolescence analysis, and training support to resolve issues in a timely fashion. • Mentored and provided training for cross discipline junior engineers. • Recognized as technical specialist in Agile data management system, component obsolescence, RoHS & REACh compliance and Microsoft Office.
Primary responsibilities – Product development, V&V creation and execution. · Developed and executed V&V protocols for new medical device that qualifies human organs for transplant. · Designed and upgraded LabVIEW motion control interface and data collection system for a prototype medical specimen processing device.
Primary responsibilities - support customer integration of Covidien R&MS products and sustaining engineering. • Managed OEM group on interim basis for 6 months. • Developed tool requirements for simplifying integration of Nellcor oximetry products. • Developed qualification test plans for OEM medical monitors. • Provided application support to expedite OEM integration products. • Performed root cause analysis of field failures. • Mentored engineers and technicians in OEM, Sustaining and V&V engineering groups in Nellcor technology, customer requirements and Covidien processes.