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Lead R&D Systems Engineer (Medtech : Sterilization)

Company: The Mullings Group
Location: Orange
Posted on: October 12, 2019

Job Description:

Verrix Sr. R & D Engineer - Systems 1330 Calle AvanzadoSan Clemente, CA 92673 Our work environment is fast-paced, exciting, and customer-driven. We partner directly with our future users in our quest to deliver value to the customers we serve. In addition, we work with top-of-the-line partners in engineering, design, regulatory affairs, and marketing, so our team is constantly interacting with the brightest minds in healthcare. Job Description:-- Participates in the mechanical design and development activities associated with the Company's electro-optical reader system and related disposables Responsible for the development of complex portions of the Company's products including fluid transfer, optical pathways, mechanical components and interfaces Responsible for the development of manufacturing processes, including fluid deposition, filling and sealing, and optical systems alignment and confirmation Performs failure analysis and develops corrective action plans Participates in vendor selection and qualification. Interfaces with project management, suppliers, electrical, software, manufacturing, tooling, and other engineering groups to ensure the successful development and launch of new products. Develops drawings, specifications, and inspection criteria Develops and produces work instructions and manufacturing processes Prepares findings and analysis in support of medical device regulatory submissions and investigations. Knowledge, Skills & Requirements: Minimum of 5-7 years' experience in mechanical and overall product design in a medical device environment Experience with optics design and fundamentals Experience with control systems and motion controls both integral to the product as well as the manufacturing processes Experience with fluid dynamics, fluid transfer and handling Experience with design for manufacturability Experience with product development practices and requirements in a regulated medical device manufacturing environment Detail-oriented with attention to product quality, Excellent problem solving and analysis skills. Must be able to write and analyze requirements, functional specifications, design specifications, test plans, and documentation. Ability to excel in a fast paced and dynamic work environment. Ability to coordinate multiple tasks toward completion targets under minimal supervision. Good communication skills, both verbal and written, and the ability to interface effectively with management and cross-functional teams. B.S. in mechanical engineering or related discipline Preference given for experience in sterilization or biological indicator product

Keywords: The Mullings Group, Orange , Lead R&D Systems Engineer (Medtech : Sterilization), Other , Orange, California

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