Senior Medical Device Development Engineer

Zeus; San Jose (CA); Presencial; USD 151.000 - 189.000; Jornada completa

Descripción de la vacante

Zeus Industrial Products seeks an Engineering Manager to lead product design and development of innovative medical devices, ensuring compliance with FDA QSR (21 CFR 820), ISO 13485, and QMS. You will direct engineering staff, collaborate with R&D, vendors, and cross-functional teams to meet design, validation, and cost objectives.

The role emphasizes design for manufacture, documentation, and thorough testing across bench, V&V, and in vivo environments, with global travel to customer sites as

Formación

• :Bachelor’s Degree in Mechanical Engineering is required.
• Knows catheter design and development processes.
• Experience with CAD software such as AutoCAD or SolidWorks.
• Knowledge and experience in development processes and documentation writing.
• Experience with statistical analysis and DOE is preferred.

Responsabilidades

• :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
• Lead technical discussion 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
• Conduct 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 performing 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.

Conocimientos

Catheter design

Design for manufacture

DOE

Statistical analysis

Documentation writing

Cross-functional leadership

Problem solving

Communication skills

Educación

Bachelor’s Degree in Mechanical Engineering

Master's Degree in Mechanical or Biomedical Engineering

Herramientas

AutoCAD

SolidWorks

Descripción del empleo

Zeus Industrial Products seeks an Engineering Manager to lead product design and development of innovative medical devices, ensuring compliance with FDA QSR (21 CFR 820), ISO 13485, and QMS. You will direct engineering staff, collaborate with R&D, vendors, and cross-functional teams to meet design, validation, and cost objectives.

The role emphasizes design for manufacture, documentation, and thorough testing across bench, V&V, and in vivo environments, with global travel to customer sites as