R&D Engineer

Zeus Industrial Products•San Jose, CA

1d•$97,000 - $128,700

About The Position

The R&D Engineer supports product design and development for innovative medical devices that address customer needs with complete procedural solutions. The role supports the R&D team in designing and testing catheters and delivery systems, developing concepts and detailed designs for machines, tools, and fixtures, and contributing to design for manufacturing, test-method development, and product verification and validation. The position works with cross-functional teams and external vendors, prepares specifications and engineering drawings, resolves design issues, and documents design changes and engineering work. The engineer also assists with bench, verification and validation, and in-vivo testing; develops and uses test protocols; and prepares written reports. The role may involve travel to domestic and international customer sites to gather voice-of-customer input, conduct testing, or troubleshoot. It supports design reviews and pre-validation assessments and helps ensure that designs, equipment, and work practices meet applicable company, safety, environmental, and regulatory requirements, including FDA QSR (21 CFR 820), ISO 13485, and the Quality Management System. Zeus describes itself as a polymer extrusion manufacturer and material science innovator serving industries including medical, aerospace, energy, automotive, and fiber optics. The company emphasizes continuous improvement, precision, teamwork, innovation, and customer focus.

Requirements

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
At least three years of relevant engineering experience.
Knowledge of and experience in catheter design.
Experience with CAD software such as AutoCAD or SolidWorks.
Knowledge of development processes and documentation writing.
Ability to use a PC and associated software.
Knowledge of Good Manufacturing Practices and Good Documentation Practices.
Excellent verbal and written communication skills.
Ability to work independently and manage tight timelines and changing priorities.
Excellent problem-solving skills.
Proficiency with Microsoft Office applications.
Ability to provide technical leadership on cross-functional teams.

Nice To Haves

Master’s degree in Mechanical Engineering or Biomedical Engineering.
Experience with statistical analysis and design of experiments (DOE).
In-depth knowledge of materials and metals.

Responsibilities

Support the R&D team in designing and testing catheters and delivery systems.
Develop concepts, designs, and details for machines, tools, and fixtures.
Contribute to overall design, design for manufacturing, test-method development, and product verification and validation testing.
Participate in technical discussions and decision-making with cross-functional teams.
Act as an interface between external vendors and the core team.
Develop specifications, engineering blueprints, and detailed drawings.
Resolve design problems involving material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
Provide design changes for existing products and ensure changes are properly documented.
Create engineering designs, develop plans, and maintain laboratory notebooks documenting work.
Assist with bench, verification and validation, and in-vivo testing; develop and use test protocols; and generate written reports.
Travel to domestic and international customer sites to gather voice-of-customer input, perform testing, and/or troubleshoot.
Support design reviews and pre-validation assessments to help ensure safe and environmentally sound processes and designs.
Purchase or design equipment that meets company health, safety, and environmental standards.
Ensure personal and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.
Communicate business-related issues or opportunities to the next management level.
Perform other duties as assigned.