Mechanical Engineer

Job DescriptionJob Description

Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI’s Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver secure lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its ISO 13485 certified 110,000 square foot facility in Santa Ana, CA.

Summary of Position

The Mechanical engineer is responsible for testing and characterizing the instrumentation and microfluidics of AMDI’s point-of-care devices. Also, generating test protocols and hands-on testing of components.

Essential Duties and 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: 

1. Collaborate with other engineers to develop test plans and protocols. 
2. Fabrication drawings, wiring schematics, and instrumentation lists. 
3. 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 Required for Position

• Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, or a related field. 
• Minimum of 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).  
• Excellent analytical and problem-solving skills. 
• Strong attention to detail and documentation abilities. 
• Effective communication and teamwork skills. 
• 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. 

Desired skills and traits

• Prior medical device and microfluidics preferred. 
• Familiarity with optical elements, and components. 
• Knowledge of radiometry and STOP analysis, fluorescence detection and IFA is a plus. 
• Experience with lab equipment: power supply, oscilloscope, logic analyzer, function generator, digital multimeter, vector network analyzer, power analyzer. 
• Ability to balance multiple priorities and projects.

Work Environment

• In-person position that requires working indoors with frequent movements, bending, and lifting.
• May work in a manufacturing environment and a laboratory environment.
• Exposure to moving mechanical parts. 

Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including:

Company provided lunch to all employees when working at one of AMDI’s on-site locations.

- 401(k) match

- Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance

- Competitive vacation, sick days & paid holidays

- Tuition reimbursement

- Casual dress code

- Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.

- Monthly company-wide social

Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts.

Our commitment to an inclusive workplace:

We are an equal opportunity employer and encourage people from all backgrounds to apply.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.

Company DescriptionAMDI’s mission is to develop point of care and data distribution technologies that enable delivery of autonomous, personalized health information to patients and doctors at scale. The first product to be produced will provide a qualitative serological profile of data that can be analyzed and used to assess the person’s immunological response to COVID-19. As the virus changes and follow-up studies are designed, our data will be critical to those that are driving the studies, vaccines, and public health measures.Company DescriptionAMDI’s mission is to develop point of care and data distribution technologies that enable delivery of autonomous, personalized health information to patients and doctors at scale. The first product to be produced will provide a qualitative serological profile of data that can be analyzed and used to assess the person’s immunological response to COVID-19. As the virus changes and follow-up studies are designed, our data will be critical to those that are driving the studies, vaccines, and public health measures.]]>