iSixSigma

Senior Project Engineer

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CorTech, LLC
Published
February 19, 2021
Location
San Diego, CA
Job Type

Description

Pay rate - $53.54/hr

o Ability to work independently and to direct technicians and junior engineers
o Ability to manage multiple projects of varying scopes at once
o Develops and executes test protocols with moderate guidance
o Experience in verification testing including writing protocols and reports to support verification

Senior Project Engineer

Job Description
Primary focus of this position is to perform engineering gap assessments using various analysis means, recommend design or tool changes, update models and drawings and conduct verification testing as necessary. The candidate will conduct these activities following Design Control procedures and practices. The candidate may write test protocols, perform hands-on testing and test reports. The candidate will present work in word or power point formats to management to collaborate on next step decision making and support other activities in the collaborative environment.
Responsibilities:

  • Identify gaps in component designs to one or more ISO standards
  • Perform 3D and 2D comparative analyses as needed.
  • Work with Operations teams to understand current dimensional properties of components
  • Write test protocols as needed to determine functional performance
  • Conduct and/or oversee requisite metrology and testing (MSAs, Gage R&R)
  • Write test reports
  • Set-up test equipment and perform product tests as needed.
  • Conduct meetings to present findings, recommendations and obtain collaboration on next steps
  • Use DFSS methods to communicate test results and product confidence and reliability.
  • Facilitate building test parts for engineering evaluation and pre-clinical studies.

Qualifications:

  • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent.
  • Minimum of 3 years of experience in R&D or product development, preferably in medical device or other regulated FDA/QSR and ISO environment.
  • Must have plastic injection molding experience.
  • Experience in verification testing including writing protocols and reports to support verification activities.
  • Experience leading small projects and communication to management.

Preferred Qualifications:

  • Experience with high volume disposable products.
  • Training in Six Sigma or Design for Six Sigma. Ability to analyze data, interpret results and write reports. Proficient in statistic software, such as MiniTab, is a plus.
  • Demonstrated problem solving skills and hands-on technical aptitude
  • Excellent oral and written communication skills
  • Knowledge of cGMP and GLP is a plus.
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