Design quality engineer responsible for ensuring that medical device product development projects, for both hardware and software, are conducted in compliance with FDA and MDR Quality System Regulations including changes design projects. Responsible for product quality and reliability. Responsible for the creation and ongoing maintenance for Risk Management File documents. Support the rapid resolution of product complaints and/or safety issues (IIA).

Responsible for ensuring new development and change projects are completed in compliance with the applicable regulations and product standards for Terumo BCT's medical devices. Lead and/or collaborate with R&D and Sustaining Engineering to review designs for safety and standard compliance or remediating for revised regulations. Expert knowledge of 60601-1, 60601-1-2, and 61010-1 standards. Experience with various other part 1 and part 2 60601 standards. Supported creation and maintenance of company policies for process and product standard compliance.

Design Quality Assurance Core Team member ensuring that design and development projects for medical devices and accessories are completed in alignment with QMS, customer and regulatory compliance for both hardware and software projects. Represent the quality function in process improvements.

Engineering professional working in the equipment manufacturing operations team supporting sustaining activities, safety and EMC compliance, manufacturing, and development of medical and laboratory equipment. Involved in product lifecycle phases including development, global regulatory compliance planning/testing, transfer and post equipment manufacturing, GMP, engineering verification, component obsolescence, and design. All products require compliance to applicable FDA, IEC/EN, UL, CSA, FCC, ISO standards and EU directives. SkillsSoftware Tools: AutoCAD, Altium PCAD (Schematic Capture and Simulation), CAM 350 (PCB editor), Microsoft Office, NI LabviewTest Equipment: Digital Oscilloscope, Spectrum Analyzers, Electrical Safety Test AnalyzersRegulatory Standards: 60601-1 2nd/3rd Ed, 61010-1 2nd/3rd Ed, ISO14971, EN62366, 61010-2-20, 60601-1-2 (EMC immunity), 61326-1 (EMC immunity), 55011 (EMC emission), 60529, 60950, MDD 93/42/EEC, RoHS 2011\65\EU, WEEE, ISO13485

Accomplished and ambitious engineering technician providing technical support and training to manufacturing operations building medical devices. Create and maintain SOPs for manufacturing including routine safety testing procedures. Troubleshooting electrical assemblies to close NCs and support MRB activities. Execute verification/validation testing to support Sustaining Engineering and participating in 3rd party EMC testing for medical electrical equipment.

Responsible for performing systems checkout for medical and laboratory equipment, meeting schedule commitments, and ensuring the release of reliable and high quality medical equipment.

Supported Development and Testing of Power Supply Controller Systems, Battery Development, and DC-AC Inverter Systems.