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Development Quality Engineer II

In Minnesota / United States

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Development Quality Engineer II   

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JOB TITLE:

Development Quality Engineer II

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Plymouth Minnesota / United States

JOB DESCRIPTION:

Hello,

Hope you are doing great.

This is Greg from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to greg@intellectt.com

Role: Development Quality Engineer II

Location: Plymouth, MN

Duration: 12 Months on W2

Job Description: -

Key responsibilities

  • Lead high visibility product development quality engineering initiatives.
  • Emphasis on design control file gap assessments and remediation activity for EU MDR products.
  • This is an individual contributor role on an engineering team.
  • 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.
  • Occludes, 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

Position Details

POSTED:

Sep 12, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864754883210

LOCATION:

Minnesota / United States

CITY:

Plymouth

Job Origin:

CEIPAL_ORGANIC_FEED

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Development Quality Engineer II    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Hello,

Hope you are doing great.

This is Greg from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to greg@intellectt.com

Role: Development Quality Engineer II

Location: Plymouth, MN

Duration: 12 Months on W2

Job Description: -

Key responsibilities

  • Lead high visibility product development quality engineering initiatives.
  • Emphasis on design control file gap assessments and remediation activity for EU MDR products.
  • This is an individual contributor role on an engineering team.
  • 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.
  • Occludes, 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


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