Mechanical Engineer

Job Description

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 [email protected] and visit our website at www.biophaseinc.com for additional job opportunities!!!