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Staff Mechanical Engineer - Advanced R&D

Irvine, CA 92618

Posted: 11/12/2024 Employment Type: Direct Hire Industry: Electro-Mechanical Engineer Job Number: 20733 Pay Rate: $104,000 - $165,000

Job Description

The Staff Mechanical Engineer provides engineering and design services to Advanced R&D. This includes ideation, developing concepts and prototypes, creating test methods, supporting preclinical/clinical testing of the device, and supporting technical transfer. This position will have responsibilities across Companies including a span of multiple product platforms such as Electrophysiology, Neurovascular, Vision, and Surgical and Non-Surgical Aesthetics.

Key Duties:
• Designs new devices based upon customer need
• Optimizes processes for initial and long-term scaling of new designs and processes for the designs
• Works directly with other engineers and skilled technicians to build and optimize designs
• Tests design prototypes and modifies design based upon test results
• Participates in in vitro and in vivo device testing
• Documents design and performs testing for V&V activities
• Manages the transfer of designs from concept to pilot to full production
• Works with cross-functional quality, medical affairs, and manufacturing teams
• Motivates and mentors others
• Creates IP and works with patent attorneys to ensure patents are applied for
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Performs other duties assigned as needed

Qualifications:

Required:

• A minimum of a BS in physics, chemistry, biology, mechanical, electrical, biomedical engineering, or related field
• A minimum of 6+ years of engineering work experience, with 2+ years of experience in the medical device industry
• Ability to travel up to 10%, domestic and international
• A minimum of 1 year of experience working in a pre-clinical or clinical environment
• Proven experience designing and prototyping mechanical devices

Preferred:
• Knowledge of geometric dimensioning and tolerancing (GD&T)
• Strong knowledge of CAD software including SolidWorks
• Able to interpret 2D engineering drawing
• Previous experience in cardiac electrophysiology
• Previous experience working with physicians
• 2+ years of R&D experience
• Understanding of quality standards pertaining to medical device
• Experience with statistical analysis and design of experiments (DOE)
• Knowledge of engineering materials such as nitinol, precious metals, and/or polymers and manufacturing techniques related to the materials
• Ability to work with patent attorneys to secure IP
 

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