Principal R&D Engineer - Medical Devices

About the role

Terumo Neuro is looking for a Principal R&D Engineer in Aliso Viejo, California, to support and lead the development of medical device products. The role covers writing or verifying specifications, maintaining product processes, designing fixtures and testing processes, equipment and raw materials so that concepts and prototypes meet their requirements.

Key responsibilities

• Develop new product concepts using mechanical, electrical, materials, bioengineering or other relevant disciplines.
• Provide engineering design and process development, and sustain engineering support.
• Build products, processes and supporting capabilities such as test methods, equipment/fixtures, data engineering, statistics, software coding, engineering/business intelligence and analytical methods.
• Generate intellectual property and write invention disclosures.
• Specify and direct the specification and testing of new materials and designs, and coordinate with departments and outside services to refine designs.
• Support projects through regulatory submissions and approvals, largely self-directed with minimal supervision.
• Lead projects, mentor Assemblers, Technicians and others as needed, and lead test method development, data analysis, root cause investigations and formal test report release.
• Comply with laws and regulations, follow Quality Management System processes and act with ethics and integrity.

Required profile

• Bachelor's degree in mechanical engineering, industrial engineering or materials science engineering.
• At least 10 years of relevant work experience in the medical device industry.
• Strong written and verbal communication skills.
• Ability to design and develop medical devices and to read and prepare technical documentation.
• Working knowledge of medical device manufacturing equipment and processes.

Required skills

• Expert proficiency with MS Word, Excel, PowerPoint, Minitab and SolidWorks or other CAD systems.
• Knowledge of medical and technical development.
• Desired: advanced degree, ability to manage internal and external customers and lead key players, and ability to work across departments and meet deadlines.