Project Engineer-Medical Devices (Design)

Company: Biolink360
Location: Los Angeles
Posted on: November 13, 2024

Job Description:

Project Engineer - Medical Devices (Design)Position Type: HybridSalary: 110K-160K, depending on level of experienceOur client is a company focused on the medical device industry hiring a Project Engineer. Engineers with backgrounds in design, development, sustaining, and QMS could find a fit here. This opening is due to company growth!This company specializes in custom product development for the medical device industry, serving clients worldwide. They are dedicated to bringing innovation to market and have developed complex medical devices for various surgical specialties including spine, orthopedics, general surgery, dental, ophthalmology, and urology.The hired Engineer will be a salaried employee working on a team that handles full cycle product development and post-market surveillance activities, managing a wide range of projects simultaneously.The Engineer 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 is a full-time, salaried role with full corporate benefits, within a small team of tenured Design and Quality Engineers and Regulatory Affairs SMEs, fostering 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.
• Provide assistance with Design Control documentation.
• Develop Validation and Testing Protocols.
• Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements.Qualifications
• Bachelor's Degree in Engineering, Science, or a health-related field.
• 4-10 years of related work experience in the medical device industry, with Design and Development.
• Working knowledge of FDA and other regulatory authorities with experience supporting compliance.
• AND/OR 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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Keywords: Biolink360, Orange , Project Engineer-Medical Devices (Design), Engineering , Los Angeles, California