Future Opportunities - Join Our Talent Pipeline for R&D Device Engineer – Mechanical, Electrical, or Software Engineer
$35,000–$172,500 year
On-site · Irvine, California, United States
Job Summary
Device Engineer will act as a technical lead on medical device product development projects, guiding design and testing of components and subassemblies from concept through production transfer. Responsibilities include mentoring team members, managing parts/subassemblies development, interfacing with Clinical and Marketing to determine design requirements, outlining short-term goals to achieve milestones, conceiving/designing/building/evaluating prototypes, presenting designs at technical reviews, refining concepts with minimal supervision, evaluating materials, adhesives and assembly techniques, selecting vendors for prototypes and providing production-recommendations, applying DFMA principles, planning and documenting verification testing, assisting in transfer methods to manufacturing, and maintaining ECO changes within the Document Control system. The role requires collaboration across ME and R&D groups, resolving design conflicts with minimal managerial intervention, and ensuring compliance with FDA QSR, ISO13485, and Canadian Medical Device Regulations; a BS in engineering, extensive product design experience, and strong communication skills are essential.
Required Qualifications
- BS in Mechanical, Software, Electrical Engineering or equivalent degree
- At least eight years of product design and development experience; prefer ten years
- Prefer at least three years of experience in medical devices, ideally class II devices
- Individual will complete work with minimal supervision of the manager; typically the technical leader
- Proficient with basic standard concepts and constraints involved in creating new product designs
- Should be knowledgeable of new modern methods for making prototype or production parts
- Ability to set medium term project goals and outline schedules for multiple tasks for several team members
- Strong verbal and written communication skills
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