Staff Engineer, R&D

Terumo Group; Aliso Viejo (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

A medical device company in Aliso Viejo, California, is seeking a qualified engineer to support the design and manufacture of medical devices. Responsibilities include developing 3-D designs using SolidWorks, collaborating with cross-functional teams, and ensuring compliance with regulations. Candidates should have a Bachelor's degree in Engineering, six years of relevant experience in the medical device field, and strong communication skills. This role offers a chance to significantly impact the development and sustaining efforts of innovative healthcare products.

Qualifications

• Minimum six (6) years of relevant work experience in the medical device industry.
• Experience designing components optimized for injection molding.
• Working knowledge of medical devices and FDA regulations.

Responsibilities

• Work in cross-functional teams to identify customer needs and develop design solutions.
• Translate abstract ideas into design solutions using various methods.
• Develop test plans, protocols, and reports for design verification and validation.

Skills

Strong design expertise using SolidWorks

Strong written and verbal communication skills

Working knowledge of fundamental mechanical engineering principles

Proficient computer skills, including MS Word, Excel, Outlook, and Teams

Education

Bachelor’s degree in Engineering or Scientific field

Advanced degree in Engineering or Scientific field

Tools

SolidWorks

Finite Element Modeling

Job description

Support the design and manufacture of medical devices, including creating 3‑D designs using design software such as SolidWorks, generating detailed 2‑D drawings, writing engineering requirements, developing test methods and test fixtures, supporting product manufacturing, and solving issues throughout design, development, design transfer launch, and post‑market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory teams 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.
• 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 the optimum solution for the application.
• Develop and test prototypes as required during the course of product development.
• Release revision‑controlled designs and documentation in the document control system.
• Support the design transfer of products 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, and demonstrate ethics and integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Qualifications

• 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 2‑D drawings, and BOMs.
• Proficient computer skills, including MS Word, Excel, Outlook, and Teams.
• 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.