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Product Development Engineer

Job Attributes

Job Id:

19149

Job Category:

Clinical & Life Sciences

Job Location:

King Of Prussia, PA  19406

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is currently looking for a Product Development Engineer in King of Prussia to join a pioneer in spinal medical devices.

Responsibilities of the Product Development Engineer include:

  • Author and approve DHF and tech file documentation
  • Responsible to ensure that activities are in compliance with Regulations (QSR, CMDR and MDD), Standards (ISO 13485) and the Quality Management System Manual
  • Utilize Solidworks/Creo CAD and FEA to design models and drawings
  • Post market surveillance

Qualifications for the Product Development Engineer:

  • 3+ years’ experience quality within an ISO 13485/FDA regulated company
  • Experience progressing from conceptualization to realized product launch for a Class III or II spine or orthopedic implant system
  • Working knowledge of orthopedic devices and engineering drawings
  • Exposure to outside/external suppliers/surgeons
  • Bachelor’s Degree in Engineering required

Compensation for the Product Development Engineer position includes:

  • Salary Range: $70,000-$80,000, depending on experience
  • Full Benefits: Medical, Dental, PTO

Please send resumes to Karen Pallone at kkpallone@pipercompanies.com

Keywords:

ISO 9001, international regulations, QA/QC, quality assurance, ISO 13485, FDR CFR Part 82, Six Sigma, ASQ, cGMP, ISO, manufacturing, medical devices, machines, CAPA, quality engineering, change controls, validation, regulatory affairs, EU regulatory, CER, clinical evaluation reports, spinal

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New Search

Job Id:

19149

Job Category:

Clinical & Life Sciences

Job Location:

King Of Prussia, PA  19406

Security Clearance:

No Clearance

Business Unit:

Piper Companies