Staff Engineer, Quality

3 weeks ago

Aliso Viejo, United States MicroVention Full time
Job Description

Work with R&D and Manufacturing to lead design control activities for the development and manufacture of medical devices and resolve product quality issues. Provide the quality/independent review at design reviews. Review and provide guidance for project design plans, risk management, design verification/validation, and process validation. Provide quality guidance for design changes to existing product lines. Job duties:
  • Provide technical skills in many areas of quality assurance such as design control, risk analysis, design verification, design validation, process validation, test method validation, statistical sampling, and data analysis.
  • Work with R&D on design verification and design validation testing of new products.
  • Work with R&D and Quality Engineers on preparing quality specifications and receiving specifications.
  • Conduct or review test method validations.
  • Coordinate implementation of new equipment by reviewing equipment specifications and related qualifications.
  • Prepare or review risk analysis documents including product risk assessments and FMEAs.
  • Participate in developing improvements to quality system procedures.
  • Largely self-directed and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
  • Work with R&D Engineers to provide design and development documents to the Regulatory department for preparing the PMA, 510(k), special 510(k), and/or European submission files.
  • Work with R&D to address issues related to the submission files.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.


Qualifications

  1. Bachelor's degree in Engineering or related field.
  2. Minimum six (6) to eight (8) years of relevant work experience in Manufacturing, Quality Engineering/Quality Control and Operations, R&D, design control, risk analysis, design verification, design validation, process validation, test method validation and data analysis.
  3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (ISO 14971, ISO 13485, 21CFR820).
  4. Demonstrated experience with of electrical/electromechanical type testing requirements (IEC60601 standards series).
  5. Demonstrated experience with medical devices software requirements (ISO 62304).
  6. Proven experience in statistical analysis (statistical analysis tools).
  7. Strong written and verbal communication skills.
  8. Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab, Design of Experiment DOE, etc.).
Desired Qualifications
  1. Ability to provide technical leadership in process validation, test method validation, data analysis, design control, risk analysis, design verification, and design validation.
  2. Strong knowledge of the medical device design control process.
  3. Ability to understand the technology related to MicroVention's products.
  4. Demonstrated experience with active implantable devices and associated requirements (ISO 14708).
  5. Demonstrated experience with mobile application software for medical devices and associated requirements.
  6. Prior experience with medical device cybersecurity requirements.
  7. Strong knowledge of medical product quality assurance.
  8. Strong mathematics skills with working knowledge of statistical tools.

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