Medical Device Design Assurance Engineer

Providence, RI

Industry: Medical Device Job Number: 134297


Medical Device Design Assurance Engineer

Our client is a fully integrated product development firm focused on bringing medical and diagnostics technologies from first concept to market launch. They are looking for a ‘ go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories. They are looking for a Design Assurance Engineer to have experience in Risk Management Activities and a strong understanding of ISO 14971. They need to be well versed in design Verification, Process Validation, and developing user needs and design inputs. They need to be a great communicator that can converse with cross functional teams from other major medical device companies.   They need to have an understanding of FDA Quality System regulations, EU Active Implantable & Medical Device Directives, ISO 13485 principles.

Day to Day Responsibilities include:
  • Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
  • Takes an active role to ensure products meet corporate, industry, and regulatory standards
  • Participates in the technical review of design input specifications and design documentation for new medical devices
  • Participates in the development of system specifications
  • Plans, develops, and executes verification testing for products under development
  • Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities
  • Completes component part qualification activities including first articles, cap studies, gage R&R, and implementation of SPC requirements
  • Supports product/process transfers during pilot and manufacturing builds
  • Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
  • Establishes programs to evaluate analytical testing, equipment, facilities, precision measurements, accuracy measurements, and performance testing
  • Plans, executes or directs activities concerned with development, application, and maintenance of quality standards. Reports results to marketing, manufacturing, process engineering, and product design groups
  • Lead or assist in quality evaluation of returned products and support RMA program
  • Lead, participate in, or coordinate Internal Corrective Action initiatives
  • Performs internal quality and design control audits
  • Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements



Job Type: Contract 

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