Staff Optical Engineer, R&D

Terumo Group; Aliso Viejo (CA); On-site; USD 111,000 - 146,000; Full time

Job summary

An established industry player is seeking a skilled engineer to support the design and manufacture of innovative medical devices. This role involves creating 3D designs, developing test methods, and collaborating with R&D and manufacturing teams to ensure seamless product launches. You'll leverage your expertise in SolidWorks and mechanical engineering principles to solve complex design challenges and support product sustainment. Join a forward-thinking company dedicated to improving healthcare through cutting-edge technology and make a significant impact in the medical device field.

Qualifications

• 6+ years of experience in the medical device industry with strong design expertise.
• Bachelor's degree in Engineering or Scientific field is required.

Responsibilities

• Design and manufacture medical devices, including 3D designs and detailed drawings.
• Work with cross-functional teams to meet customer needs and develop specifications.

Skills

Mechanical Engineering Principles

Design Expertise using SolidWorks

Communication Skills

Problem Solving

Prototyping

Education

Bachelor’s degree in Engineering or Scientific field

Advanced degree in Engineering or Scientific field

Tools

SolidWorks

MS Word

MS Excel

MS Outlook

MS Teams

Job description

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:

• 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 a 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 prototypes 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:

12637BR

Salary Range:

$111,000 - $146,000 (Compensation could be higher/lower based on experience, education, and skill sets)

Minimum Requirements:

• Bachelor’s degree in Engineering or Scientific field.
• Minimum six (6) years of relevant work experience in the 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 the 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.

Preferred 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 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.