R&D Engineer

Zeus Industrial Products•San Jose, CA

About The Position

The R&D Engineer supports product design and development projects focused on innovative medical devices and complete procedural solutions. The role supports the design and testing of catheters and delivery systems, including overall design, design for manufacturing, test method development, and product verification and validation. It also contributes to the design and improvement of products, machines, tools, and fixtures, while complying with FDA QSR (21 CFR 820), ISO 13485, and the company Quality Management System. The engineer collaborates with cross-functional teams and external vendors, develops engineering specifications and drawings, addresses design issues, documents product changes, and maintains engineering plans and laboratory notebooks. The position also supports bench, verification and validation, and in vivo testing; prepares test protocols and reports; and may travel domestically and internationally to customer sites for voice-of-customer activities, testing, or troubleshooting. The role supports design reviews and pre-validation assessments and helps ensure equipment and processes meet applicable health, safety, environmental, and regulatory requirements.

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 and experience in development processes and documentation writing.
Ability to use a PC and associated software.
Knowledge of Good Manufacturing Practice and Good Documentation Practice.
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.

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, including design for manufacturing, test method development, and product verification and validation testing.
Participate in technical discussions and decision-making with cross-functional teams.
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 and document design changes for existing products.
Create engineering designs and 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 information, perform testing, or troubleshoot.
Support design reviews and pre-validation assessments to help ensure safe and environmentally sound processes and designs.
Support the purchase or design of 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.