Job description

Position Overview Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustainment. Job Duties: 1. Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs 2. Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D models, mock-ups, and prototypes 3. Communicate technical concepts effectively to non-technical team members to facilitate cross-functional understanding 4. Develop test plans, protocols, and reports as part of design verification and validation 5. Develop designs that are robust and optimized for manufacturability 6. Evaluate different design solutions and components to determine optimum solution for the application 7. Develop and test protypes as required during the course of product development 8. Release revision-controlled designs and documentation in document control system 9. Support the design transfer of product from R&D to Manufacturing for volume production 10. Train Technicians to assemble and test mechanical systems 11. Develop and maintain vendor relationships 12. Assist with solving technical challenges encountered during manufacturing 13. Support post market sustaining efforts (e.g., complaint investigations, product training) 14. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization 15. Perform additional duties as assigned Job Details Job ID 13597BR Aliso Viejo, California, USA Salary Range: $116,706 - $153,176 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand) Apply for this job • Qualifications • Bachelor’s degree in Engineering or Scientific field. • Minimum six (6) years of relevant work experience in medical device industry. • Strong written and verbal communication skills. • Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics. • Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs. • Proficient computer skills, including MS Word, Excel, Outlook, and Teams. Desired Qualifications • Advanced degree in Engineering or Scientific field. • Experience designing components optimized for injection molding. • Experience with developing user centric industrial designs for medical devices. • Experience with Finite Element Modeling. • Experience designing complex mechanical/electromechanical systems. • Experience designing enclosures, chassis, and spatial packaging of components. • Working knowledge of medical devices and FDA regulations. • Experience with CAPA systems, including complaint handling. • Ability to receive the appropriate inoculations required to enter an operating room environment.

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Position Overview
Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs
Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D models, mock-ups, and prototypes
Communicate technical concepts effectively to non-technical team members to facilitate cross-functional understanding
Develop test plans, protocols, and reports as part of design verification and validation
Develop designs that are robust and optimized for manufacturability
Evaluate different design solutions and components to determine optimum solution for the application
Develop and test protypes as required during the course of product development
Release revision-controlled designs and documentation in document control system
Support the design transfer of product from R&D to Manufacturing for volume production
Train Technicians to assemble and test mechanical systems
Develop and maintain vendor relationships
Assist with solving technical challenges encountered during manufacturing
Support post market sustaining efforts (e.g., complaint investigations, product training)
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
Perform additional duties as assigned
Job ID 13597BR
Aliso Viejo, California, USA
Apply for this job
Qualifications • Bachelor’s degree in Engineering or Scientific field.
Minimum six (6) years of relevant work experience in medical device industry.
Strong written and verbal communication skills.
Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.
Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs.

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