Technical Engineer

Location: Irvine, California, United States
Salary: competitive
Sectors: R&D
Job Type: Contract
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Role:

Class III remediation project. The person in this role will be responsible for providing technical expertise to support ongoing engineering activities that enhance or sustain their products.

Responsibilities:

  • Development and execution of testing approaches on projects: drafting test plans and reports..
  • Conceptualize, develop and validate test methods in support of product development and regulatory submissions.
  • Support component qualification and the development of PDP documents
  • Document all work according to GMPs and SOPs in compliance with the company's quality system.
  • Work with engineers to evaluate designs for new products, product revisions, components, assemblies or tools.
  • Collaborate with R&D, Manufacturing, Regulatory and Quality departments to coordinate focused efforts on investigations.
  • Assess failure modes and conduct risk analyses.
  • Mitigate risks associated with identified hazards in Design and Process FMEA.
  • Excellent teamwork and organizational skills.
  • Excellent written and verbal communication skills.

Qualifications:

  • Minimum 4 years of engineering experience
  • Minimum 3 years of Class III medical device experience required
  • Bachelors Degree in Engineering: Mechanical, Biomedical, or Boengineering
  • Experience with R&D: designing tests, writing protocols, executing tests, compiling data, completing all necessary documentation
  • EU MDR experience preferred

Sthree US is acting as an Employment Business in relation to this vacancy.

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