Full-Time Lead Engineer Based in Irwindale, CA or Cincinnati, OH
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)
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.
- 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 ApplyApply Resume at firstname.lastname@example.org
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