BOSTON SCIENTIFIC CORPORATION – $76,939.00/Year

Bachelors degree in Biomedical Engineering, Biotechnology Engineering, or related field plus 24 months experience as a Design Quality Assurance Engineer or related occupation. Requires experience in each of the following skills FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, and product risk management; US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971 Risk Management, and EN 62366 Usability; Minitab Statistical Analysis software to perform statistical analysis through ANOV A, Sample urTtests and sampling plan development for validation and comparative studies; Clinical understanding of ological procedures; IEC 60601 family and IEC 62304 to provide quality and compliance input and coaching for product development andor post market product sustaining activities, such as design changes, supplier auditing and surveillance, product CE marking and safety certification, customer complaint investigations; Lead CAPA efforts, and apply sound, systematic problemsolving methodologies identifying, prioritizing, communicating and driving resolution of quality issues; and Medical Device Labeling as it relates to standards compliance and risk controls.