Sr. Design Assurance Engineer

CathX Medical

  • Arden Hills, MN
  • $101,000-124,000 per year
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Purpose of Position:The Design Assurance (DA) Engineer works as an integral part of the CathX engineering team responsible for developing and manufacturing high quality medical products. This role is the leading voice of quality in new product development, technology transfers, and process development. Responsible to provide Design Assurance Engineering support for transfer and design verification projects as detailed below:Essential Functions:
  • Establish design verification protocols and reports with input from the project manager and manufacturing engineering. Perform independent verification of test data and analyze results.
  • Define and provide input on test methods, test method validation, and general testing requirements to ensure that standards, regulations and guidance document criteria are met.
  • Support process validation and technology transfer studies for special processes to improve CathX manufacturing capability.
  • Develop master validation plans and reports based on input from customers' and project teams.
  • Support all aspects of risk management including hazard analysis, Design FMEA and Process FMEA for DV and TX projects
  • Review and provide input on calibration, preventive maintenance, IQ/OQ, PQ and software validation protocols for inspection, measuring, manufacturing, and testing equipment.
  • Obtain and gain agreement on any special quality, test, and certification requirements in cooperation with the project team and assure overall agreement between CathX and customer drawings and specifications for DV and TX projects.
  • Draft and execute design of experiments (DOE) and capability studies with the input and support of the manufacturing engineer and project manager.
  • Work as a part of a core team with R&D, Project manager, Manufacturing engineering and business development as required in new product introduction for DV and TX projects.
  • Perform statistical analysis of test data and inspection results for new product introduction.
  • Perform internal audits as part of an audit team at the direction of the lead auditor.
  • Promote a culture of compliance to company procedures.
Required Experience, Knowledge, Skills, Abilities or Education:
  • Five or more years of experience in quality engineering, manufacturing engineering, and project engineering.
  • BS degree in science, engineering, or manufacturing or equivalent experience or certifications.
  • Demonstrated expertise in quality concepts, practices, and procedures and risk management.
  • Strong interpersonal skills are required.
  • Strong design for manufacturability skillset preferred
  • Demonstrated ability to define, document, execute and analyze data from verification and validation testing
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Ability to travel as necessary.
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CathX Medical