Staff Engineer, R&D

Company: Terumo Cardiovascular Systems Corporation
Location: Aliso Viejo
Posted on: May 4, 2025

Job Description:

$111,149 - $138,936 (Compensation could be higher based on education, experience and skill sets)Job DescriptionSupport the design and manufacture of medical devices, including creating 3-D designs using 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, Operations, Quality, and Regulatory teams to support new product development and manufacturing process transfer, ensuring smooth transition to Manufacturing Engineering and Production for launch, and ongoing product support.Job duties:

• Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings.
• Translate abstract ideas into design solutions using methods such as sketches, 3D models, mock-ups, and prototypes.
• Communicate technical concepts effectively to non-technical team members.
• Develop test plans, protocols, and reports for design verification and validation.
• Create robust and manufacturable designs.
• Evaluate design solutions and components to determine optimal options.
• Develop and test prototypes during product development.
• Manage revision-controlled designs and documentation within the document control system.
• Support the transfer of designs from R&D to Manufacturing for volume production.
• Train technicians in assembly and testing of mechanical systems.
• Develop and maintain vendor relationships.
• Assist in solving technical challenges during manufacturing.
• Support post-market activities such as complaint investigations and product training.
• Ensure compliance with applicable laws, regulations, Quality Management System processes, and demonstrate ethics and integrity.
• Perform additional duties as assigned.Qualifications:

• Bachelor's degree in Engineering or Scientific field.
• Minimum six (6) years of relevant experience in the medical device industry.
• Strong communication skills.
• Knowledge of mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.
• Expertise in SolidWorks, capable of creating complex designs, detailed 2D drawings, and BOMs.
• Proficient with MS Word, Excel, Outlook, and Teams.
  • Advanced degree in Engineering or Scientific field (preferred).
  • Experience designing components for injection molding.
  • Experience in user-centric industrial design for medical devices.
  • Experience with Finite Element Modeling.
  • Design experience for enclosures, chassis, and spatial packaging.
  • Knowledge of medical device regulations and FDA requirements.
  • Experience with CAPA systems and complaint handling.
  • Ability to receive inoculations for operating room environments.
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Keywords: Terumo Cardiovascular Systems Corporation, Oceanside , Staff Engineer, R&D, Engineering , Aliso Viejo, California