Medical Devices R&D Engineer - Catheter Design & Innovation

Zeus; San Jose (CA); On-site; USD 97,000 - 129,000; Full time

Job summary

Zeus Industrial Products is seeking an Engineering Manager to oversee the design and development of innovative medical devices, focusing on catheter systems and delivery devices. You will lead engineering staff to align with FDA QSR 21 CFR 820, ISO 13485, and the QMS, ensuring quality and regulatory compliance.

The role requires hands-on CAD experience (AutoCAD/SolidWorks), 3+ years in engineering, and strong documentation and DOE skills.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering is required.
• Master's Degree in Mechanical or Biomedical Engineering is preferred.
• Must have three (3) plus years’ relevant Engineering experience
• Knowledge and experience in catheter design is required.
• Experience with CAD software such as AutoCad or Solidworks is required.
• Knowledge and experience in development processes and in documentation writing is required.
• Experience with statistical analysis and design of experiments (DOE) preferred.
• Ability to use PC and associated software is required.
• In-depth knowledge of material and metals is preferred.
• Knowledge of Good Manufacturing Process and Good Documentation Practice.

Responsibilities

• Support R&D team to design and test catheters and delivery systems
• Develop concepts, designs and details for machines, tools and fixtures.
• Support includes overall design, design for manufacturing, test method development, and product verification and validation testing
• Participate in technical discussions and decision making with cross functional team.
• Interface between external vendors and core team.
• Develop specifications, engineering blueprints and detail drawings.
• Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Provide design changes for existing products. Ensures proper documentation of changes.
• Create engineering designs, develop plans and keep laboratory notebooks on all work.
• Assist with testing (Bench, V&V, in vivo); develop and utilize test protocols; generate written reports.
• Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
• Responsible for supporting design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Performs other duties assigned as needed.

Skills

Catheter design

DOE

Statistical analysis

Documentation writing

PC software proficiency

Independent work

Education

Bachelor's Degree in Mechanical or Biomedical Engineering

Master's Degree in Mechanical or Biomedical Engineering

Tools

AutoCAD

SolidWorks

Job description

Zeus Industrial Products is seeking an Engineering Manager to oversee the design and development of innovative medical devices, focusing on catheter systems and delivery devices. You will lead engineering staff to align with FDA QSR 21 CFR 820, ISO 13485, and the QMS, ensuring quality and regulatory compliance.

The role requires hands-on CAD experience (AutoCAD/SolidWorks), 3+ years in engineering, and strong documentation and DOE skills.