Sr Development Engineer

Zeus; San Jose (CA); On-site; USD 151,000 - 189,000; Full time

Job summary

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

Qualifications

• :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.

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
• 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.

Skills

Catheter design

Design for manufacture

DOE

Statistical analysis

Documentation writing

Cross-functional leadership

Problem solving

Communication skills

Education

Bachelor’s Degree in Mechanical Engineering

Master's Degree in Mechanical or Biomedical Engineering

Tools

AutoCAD

SolidWorks

Job description

Job Description

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

Job Description

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

Responsibilities

ESSENTIAL FUNCTIONS:

• 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.

Supervisor Responsibilities

The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.

QUALIFICATIONS

• Bachelor’s Degree in Mechanical Engineering is required.
• Master's Degree in Mechanical or Biomedical Engineering is preferred.
• Must have five (5) 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 required.
• Knowledge of Good Manufacturing Process and Good Documentation Practice.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

• Values: Integrity, Accountability, Teamwork, Innovation
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to manage tight timelines and changing priorities
• Excellent problem -solving techniques
• Proficient with Microsoft office applications
• Skilled at providing technical leadership on cross-functional teams

Pay range is $151,000-$189,000

About Us

Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world’s leading polymer extrusion manufacturer and material science innovator. More than 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more allows us to set the bar high.

Zeus is a great place to work. Expectations are high; our work is meticulous and very precise. Zeus offers an opportunity to join a very successful, family-oriented team. Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. We are a leader in our field and have great relationships with our customers and team members. Many of our team members are the best at what they do in the world. Our customers are leaders in their fields. Our products help save lives.

Continuous Improvement is a way of life at Zeus. Successful candidates will have a desire and ability to take our manufacturing process to the next level. Expectations are high; our work is meticulous and very precise. You must possess the ability to work independently; and the desire to learn a variety of skills. The ability to communicate clearly is imperative, as is the ability to manipulate data using various software packages.

At Zeus, what we do matters, and we pride ourselves in “Turning polymers into possibilities.” Expectations are high; our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none.

Our Employees And Our Customers Are At The Center Of Everything We Do. Those Relationships Have Been Built On a Foundation That Is Supported By Our Mission And Vision

Our Mission: Provide Solutions – Enable Innovation – Enhance Lives

Our Vision: Working Together – Doing It Better

Zeus is an exciting, innovative company that offers competitive pay and a great benefits package. As we continue to push the boundaries of polymer science, we’re constantly in need of new ideas, new expertise, and new team members. Are you ready to join us?