Development Quality Engineer II

Job Description:

• Lead high visibility product development quality engineering initiatives.
• Emphasis on design control file gap assessments and remediation activity for EU MDR products.
• Typical day - Perform EU MDR gap assessments for assigned products. Analyze and evaluate product/customer risks (UFMEA, DFMEA and Hazard Analysis).
• Review CAPAs, deviations and non-conformance reports to understand issues and judge appropriateness of outcomes.
• Partner with R&D to create/execute new protocols and reports (test methods, design verification, design validation, etc).
• Populate GSPR documentation (General Safety and Performance Requirements). Collaborate with other functional groups as necessary to ensure timely and accurate EU product submissions.
• Basic knowledge - Understand design control procedures and development processes. Be able to identify/create technical documentation to show evidence of compliance. Navigate Design History Files and supporting documentation evidence.
• Required experience - Demonstrated ability to author protocols, reports, and technical justifications (TMV/DV/Design Validation/OQ/PQ/PPQ).
• Products Supported - Permanently implanted heart repair and treatment devices. Occluders, delivery devices, surgical & transcatheter heart valve products plus accessories.

Candidates need to be prepared to provide detailed examples of the type of work they performed. process validation knowledge and experience is a requirement.

• Job Description:

  • Lead high visibility product development quality engineering initiatives.
  • Emphasis on design control file gap assessments and remediation activity for EU MDR products.
  • Typical day - Perform EU MDR gap assessments for assigned products. Analyze and evaluate product/customer risks (UFMEA, DFMEA and Hazard Analysis).
  • Review CAPAs, deviations and non-conformance reports to understand issues and judge appropriateness of outcomes.
  • Partner with R&D to create/execute new protocols and reports (test methods, design verification, design validation, etc).
  • Populate GSPR documentation (General Safety and Performance Requirements). Collaborate with other functional groups as necessary to ensure timely and accurate EU product submissions.
  • Basic knowledge - Understand design control procedures and development processes. Be able to identify/create technical documentation to show evidence of compliance. Navigate Design History Files and supporting documentation evidence.
  • Required experience - Demonstrated ability to author protocols, reports, and technical justifications (TMV/DV/Design Validation/OQ/PQ/PPQ).
  • Products Supported - Permanently implanted heart repair and treatment devices. Occluders, delivery devices, surgical & transcatheter heart valve products plus accessories.
  Candidates need to be prepared to provide detailed examples of the type of work they performed. process validation knowledge and experience is a requirement.