Mechanical Engineer

Job 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 and visit our website at for additional job opportunities!