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Form of workJob Description
BioPhase 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: $70-95k
Responsibilities:
- 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!!!
