Mechanical Engineer

4 weeks ago

Orange County, United States BioPhase Solutions Full time
Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Mechanical Engineer to work for an Orange County area medical device company.Salary: $70-95kResponsibilities:
  • Generation of Test Protocols and Reports for both R&D feasibility testing and for meeting regulatory requirements (such as Verification and Validation studies).
  • Design and fabricate electrical/mechanical test stands, tools, and fixtures for use in testing. This includes:
    • Collaborate with other engineers to develop test plans and protocols.
    • Fabrication drawings, wiring schematics, and instrumentation lists.
    • Constructing parts using either internal tools (such as 3D printing, laser cutting, CNC machining) or sending out to appropriate vendors when needed.
  • Must be hands on and have significant experience using electronic equipment and test tools (oscilloscope, multimeter, function generator, SMD soldering equipment)
  • Maintain and upkeep of tools and equipment.
  • Analyze user requirements, regulatory guidelines, and industry standards to define system specifications.
  • Ensure that the developed systems meet all regulatory requirements, such as FDA (Food and Drug Administration) guidelines, ISO (International Organization for Standardization) standards, and medical device quality management systems.
  • Ensure the compatibility of different subsystems and conduct thorough system testing.
  • Verify the performance, accuracy, and reliability through validation and verification processes.
  • Identify and analyze potential risks associated with the medical device system, including errors, hardware failures, and user interactions.
  • Gather requirements, provide progress updates, and resolve technical issues.
  • Provide technical support for released medical devices.
  • Analyze field data, customer feedback, and post-market surveillance reports to identify and resolve system issues.
  • Support teams to troubleshoot problems and develop solutions.
  • Contribute to product improvement initiatives.
  • Take on additional responsibilities, tasks, projects, as the needs arise.
Qualifications:
  • Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, or a related field.
  • 2+ years of experience in testing of components.
  • Previous hands-on experience with soldering, testing tools and equipment.
  • Demonstrate knowledge of multiple disciplines, mechanical, electrical, software, etc.
  • Knowledge of medical device regulations and standards, such as FDA guidelines (e.g., 21 CFR Part 820) and ISO 13485.
  • Familiarity with medical device development life cycle and design controls.
  • Experience with validation processes (e.g., IEC 62304).
  • Familiarity with quality management systems (QMS) in the medical device industry.
  • Experience with medical imaging systems, patient monitoring devices, or other medical device technologies is a plus.
  • Experience using 2D and 3D CAD software, SolidWorks preferred.
Please send resumes to vanessa@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities

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