Design Quality Engineer- Medical Devices

Remote • Posted 3 hours ago • Updated 3 hours ago
Contract W2
Remote
$30 - $40/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • GD&T
  • DHF
  • Design History Files
  • DFMEA
  • FRA
  • Vault
  • Vault Systems
  • V&V
  • Medical Devices
  • Technical writing

Summary

JOB DESCRIPTION:

Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager. Previous system experience with Vault is preferred. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators.

Principal Duties and Responsibilities

  • Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
  • Utilize Systems to manage Document workflow
  • Generate or analyze and update existing risk documentation (DFMEA or risk tables)
  • Coordinate, prepare, and conduct design reviews with cross-functional teams
  • Perform functional relationship analyses (FRA) and tolerance stack-ups
  • Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
  • Update prints and other design and manufacturing elements
Skills:

Expected Areas of Competence

  • Familiarity with Vault Systems
  • Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
  • Strong Background in DHF documentation authoring and executing for Medical Devices
  • Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
  • Establishing a process method which meets performance and quality requirements
  • Ability to give clear and concise oral presentations
  • Technical writing
  • Microsoft Office Suite
Education:

Education Requirements

B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90944144
  • Position Id: 9102327
  • Posted 3 hours ago
Contact the job poster
AR

Ankit Rai

Recruiter @ Synkriom
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