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20 Dec 2018

Full-Time Lead Engineer Based in Irwindale, CA or Cincinnati, OH

Tehrit Inc. – Posted by Aman Irwindale, California, United States

Job Description

As a Lead Engineer, the employee will be leading multiple projects which may deal with design/process change of medical device components. He/she must have experience on working with cross functional teams and coordinates design, development, supplier quality activities as part of the project.

 Preferred education background:

B.S. degree in Mechanical Engineering (Industrial or Biomechanical degree with high related experience will be considered as well)

Qualifications:

Strong Process/Manufacturing/Development Engineering with 5 to 7 years of working experience:

  • Must have Knowledge and Experience related to the medical device industry (Understanding of FDA and Compliance regulations)
  • Experience in making mechanical design changes, following a design change process
  • Expertise in Metal Fabrication Processes: machining, castings, welding, EDM, etc.
  • DOE knowledge and use of design characterization – Six Sigma certification is a plus
  • Knowledgeable of Component and Process Qualification and Validation (Write, Execute and Complete).
  • Knowledge/Experience create test protocol, execute, and complete protocol with summary report, related to component, design and process changes.
  • Create and Execute FMEA/PFMEA.
  • Must be able to develop Gantt project plans using MS Project, Organize, Update and Manage individual project plan/schedule.
  • Must be able to create ECOs and follow-up on the approval process
  • Proficient using CAD and Solid model software to create 2D/3D mechanical component drawing/model and Sub/Final Assembly drawings.
  • Proficient in reading and creating mechanical drawings.
  • Must understand and apply GD&T on engineering drawing specifications.
  • Experience in part cost analysis or evaluation between options to manufacture.
  • Develop manufacturing tool/fixture/test equipment experience
  • Process Development – knowledge/experience in create process flow maps
  • Must have strong written and verbal communication skills, project presentations.
  • Must take ownership and accountability to manage and drive own individual projects.
  • Good technical analytical skill and logical thinking.
  • Excellent use of MS Word, Excel, PowerPoint, Minitab.

Skills:

  • Software: SolidWorks, MS Office (Word, Excel, PowerPoint, Project), Minitab
  • Hardware: Machining, Castings, Welding, EDM
  • Quality System: FDA, Component Qualification, Process Validation, PFMEA, Risk Management

How to Apply

Apply Resume at ayush@tehrit.com

Job Categories: Biotechnology / Pharmaceuticals. Job Types: Full-Time. Job Tags: Component Qualification, FDA, PFMEA, Process Validation, and Risk Management. Salaries: 80,000 - 100,000.

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