R&D Engineer (Medical Device Design)-San Diego

Description Our client is a company that is focused in the medical device industry, and they are hiring a Project Engineer with 4-8 years of experience. The person hired will be a salaried employee who will work full cycle product development and post-market surveillance activities, and be working on a wide range of projects simultaneously. The person hired into this role will have a solid background in product design, including 2D/3D CAD design and Geometric Dimensioning and Tolerancing (GD&T) experience. This person will be responsible for overseeing the manufacturing of design prototypes and production parts, working directly with clients and internal team members to meet deliverables. This position is a full time, salaried role with full corporate benefits. This is a small team of tenured Engineers and Regulatory Affairs SMEs who work closely together. This is an environment that fosters professional development, engineering excellence and a creative approach to the industry’s toughest product design and quality challenges. Responsibilities: Interface with quality, operations, and vendors to ensure manufactured products meet design intent Create and maintain device history files per FDA, ISO and other regulations Assist with development and/or revision of Quality System procedures and processes Assist with internal and supplier audit development, implementation, and execution Serve as a company representative during external audits by Regulatory and Third Party Auditors Design Control documentation assistance Validation and Testing Protocol Development Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements Qualifications: Bachelor’s Degree in Engineering, Science, or health-related field 2-10 years’ related work experience in the medical device industry Experience Required: Working knowledge of FDA and other regulatory authorities with experience supporting compliance Quality Systems development, implementation, and training experience Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training Experience with Risk Management per ISO 14971 Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls

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