Bachelor's Degree in Mechanical or Biomedical Engineering required.
Master's Degree in Mechanical or Biomedical Engineering preferred.
Minimum of three years relevant engineering experience.
Required knowledge and experience in catheter design.
Proficiency in CAD software such as AutoCAD or SolidWorks.
Experience in development processes and documentation writing required.
Familiarity with Good Manufacturing Process and Good Documentation Practice.
Responsibilities
Support R&D team in designing and testing catheters and delivery systems.
Develop concepts and designs for machines, tools, and fixtures.
Participate in technical discussions with cross-functional teams.
Interface with external vendors and core team.
Create engineering specifications, blueprints, and detail drawings.
Resolve design issues related to materials and manufacturing procedures.
Assist with testing and develop test protocols.
Benefits
Opportunity to work on innovative medical devices.
Engagement in cross-functional collaboration.
Travel opportunities for customer interaction and testing.
Focus on compliance with health, safety, and environmental standards.
Support for professional development and continuous learning.
Full Job Description
Job Description
JOB OVERVIEW 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
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.
Qualifications
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.
COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:
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
Salary range is $97,000-$128,700
Content
About Zeus Living
Zeus Living is a technology-driven property management company that offers furnished housing for business travelers and extended stays. The company was founded in 2015 by Kulveer Taggar and Joe Wong. Zeus Living provides a hassle-free living experience for its customers by offering fully furnished apartments, 24/7 support, and flexible lease terms. The company has raised over $90 million in funding and has expanded to multiple cities across the United States.
