Project Engineer Medical Products.

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  • categoria
    engineering
  • Contatto
    Christopher Woodward
  • riferimento
    23044

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Project Engineer in Medical Products

Our client is an international, innovative company specializing in wound healing solutions and products. 

Location: Full-time (3/2 Home Office)
Workload: 100%
Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include:

  • Prepare design options for product realization and develop working models and prototype

  • Identify performance, cost, quality, and timing trade-offs and implement corrective actions

  • Document product and performance requirements for product development, and future technical use; conforming to ISO, FDA, MDR, MDD and other regulatory standards

  • Provide support to Sourcing, Procurement, Marketing and Quality

  • Manage and support outsourced machine, fixture, and tool fabrication 

  • Support the Non-Conforming Report (NCR) process through reviews and disposition approvals.

  • Perform as a project resource on assigned projects

 

Qualifications:

  • Bachelor of Science (BS) degree in Engineering or related field required

  • Minimum seven years’ experience in engineering required

  • Mechanical design, materials, analysis, and manufacturing experience required

  • Plastic part design, materials, analysis, and manufacture direct experience strongly preferred

  • Electro-mechanical design, analysis and manufacturing experience strongly preferred

  • Knowledge of Sterilization and Biocompatibility medical process preferred 

  • Medical product or regulated environment experience strongly preferred

  • ASQ certifications is a plus

  • Knowledge of ISO 13485, FDA 21 CFR 820, and GMP required

  • Six Sigma Certification is preferred.

  • Must be able to read, understand and communicate in English and German

 

Physical demands

  • Travel up to 30% of the time, including occasional international travel

  • Must be able to occasionally lift and/or move up to 50 pounds

 

How to Apply:

 

Submit your application here, your detailed CV is enough. We look forward to hearing from you!

Project Engineer in Medical Products

Our client is an international, innovative company specializing in wound healing solutions and products. 

Location: Full-time (3/2 Home Office)
Workload: 100%
Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include:

  • Prepare design options for product realization and develop working models and prototype

  • Identify performance, cost, quality, and timing trade-offs and implement corrective actions

  • Document product and performance requirements for product development, and future technical use; conforming to ISO, FDA, MDR, MDD and other regulatory standards

  • Provide support to Sourcing, Procurement, Marketing and Quality

  • Manage and support outsourced machine, fixture, and tool fabrication 

  • Support the Non-Conforming Report (NCR) process through reviews and disposition approvals.

  • Perform as a project resource on assigned projects

 

Qualifications:

  • Bachelor of Science (BS) degree in Engineering or related field required

  • Minimum seven years’ experience in engineering required

  • Mechanical design, materials, analysis, and manufacturing experience required

  • Plastic part design, materials, analysis, and manufacture direct experience strongly preferred

  • Electro-mechanical design, analysis and manufacturing experience strongly preferred

  • Knowledge of Sterilization and Biocompatibility medical process preferred 

  • Medical product or regulated environment experience strongly preferred

  • ASQ certifications is a plus

  • Knowledge of ISO 13485, FDA 21 CFR 820, and GMP required

  • Six Sigma Certification is preferred.

  • Must be able to read, understand and communicate in English and German

 

Physical demands

  • Travel up to 30% of the time, including occasional international travel

  • Must be able to occasionally lift and/or move up to 50 pounds

 

How to Apply:

 

Submit your application here, your detailed CV is enough. We look forward to hearing from you!

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

CW

Christopher Woodward

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