Design Assurance Engineer

Nature of Role:

Reporting to the Director of Quality Services, this ‘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.

Requirements:

  • Bachelor’s degree in a scientific or engineering field is required
  • Experience in a new product development quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes
  • Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software
  • High level of competence in statistical techniques, including sampling plans, design of experiments, correlation and regression, analysis of variance, probability, measurement system analyses, gage repeatability and reproducibility, etc.
  • Experience with design review and design control
  • A working understanding of FDA Quality System regulations, EU Active Implantable & Medical Device Directives, ISO 13485 principles
  • Experience in Risk Management Activities and a strong understanding of ISO 14971
  • Experience in Design Verification, Process Validation, and developing user needs and design inputs

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency, Minitab experience preferred
  • Self-motivated and capable of working with minimal supervision

Responsibilities:

  • 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
  • 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
  • Lead or assist in quality evaluation of returned products and support RMA program
  • Lead, participate in, or coordinate Internal Corrective Action initiatives
  • 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
  • Performs internal quality and design control audits
  • 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
  • Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
  • 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

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