Electrical Engineer View Details

About the role

Exercises technical leadership and analytical skills in the resolution of production issues. Demonstrates creativity in implementing process improvements and new manufacturing methods including the conception, design and implementation of new tools, fixtures, and software.

Responsibilities

• Review prototype, test instructions and schematics to ascertain test specifications, procedures, and objectives.
• Interpret engineering prototypes, test instructions, and schematics to identify, modify and plan requirements for fabrication, assembly, testing and test nature of technical problems.
• Actively participate on new product release teams from the earliest phases to assure that design for manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing.
• Owns the development of assembly processes for new products as well as the introduction of new methods into the assembly processes of current products and associated PFMEA’s.
• Devise, fabricate and assemble new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules.
• Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions, make recommendations for changes in test fixtures or test methods by applying theory & principles of mechanical engineering.
• Maintain Work Instructions, BOM’s, preventative maintenance schedules, and Routers.
• Record test procedures and results; write test reports using numerical and graphical data using Excel and Word.
• Confer with engineering staff and submit reports of test results to engineering department and recommend design or material changes.

Requirements

• BS in Mechanical, Manufacturing, or Biomedical Engineering required.
• MS in Mechanical or Biomedical Engineering preferred.
• Minimum of two years’ experience.
• Prior experience in medical device industry and familiarity with FDA CGMP regulations preferred.
• Proficiency in 3D Modeling required.
• Proficiency in LabVIEW programming preferred.
• Experience in systems design.

Additional Responsibilities for Electronic Systems Engineer

This Position Is Responsible For The Design, Development, Verification, And Lifecycle Support Of Electronic Systems Used In Transonic’s Medical Devices And Life Science Instrumentation.

• Design and develop analog, RF, and digital circuits for medical devices.
• Design and review analog and digital PCB layouts.
• Troubleshoot analog and RF circuits to the component level.
• Develop test methods and verification protocols for electronic PCB assemblies.
• Perform verification testing to confirm design performance and compliance.
• Evaluate and improve existing PCB assemblies for reliability, cost, and manufacturability.

Requirements for Electronic Systems Engineer

• Bachelor’s Degree in Electrical Engineering or a related field required.
• 2-3 years’ experience preferred.
• Experience with programs for schematic capture, PC board layout, CAD and database programs.
• Experience with microcontroller programming and FPGA programming is a plus.
• Experience in regulated industries (medical device preferred) is a plus.

Quality Engineer Responsibilities

The Quality Engineer will support the quality, reliability, and compliance of Transonic’s ISO 13485 Quality Management System and medical device products.

• Serve as the primary Quality representative and process owner for the company’s NCMR program.
• Provide guidance on Quality System requirements, investigation expectations, risk evaluation, disposition decisions, documentation, and timely closure.
• Lead and coordinate cross-functional failure investigations involving nonconforming materials, components, assemblies, and finished products.
• Ensure nonconforming materials are appropriately identified, contained, evaluated, dispositioned, and documented.
• Analyze NCMR, failure investigation, deviation, and related quality data to identify trends, recurring issues, and emerging risks.

Requirements for Quality Engineer

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field required.
• 3+ years of experience in quality engineering, quality assurance, nonconforming material review or regulated manufacturing preferred.
• Prior experience in a regulated environment, preferably medical device, ISO 13485, FDA, MDR, MDSAP, or similar regulated industry, is preferred.