R&D Engineer

4 weeks ago

San Diego, United States BioLink 360 Full time

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. Are you an Engineer looking to utilize a breadth of skills and knowledge, working with a variety of technologies without having to change jobs, or be siloed in one area? Do you enjoy a small, family-like environment where people help each other be their best? (and offers a chance to work remotely)? If so, this is the opportunity for you Apply now to learn more about how you can catapult your career in the industry 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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