Engineer I - Los Angeles CA

Military Spouse Corporate Career Network•Los Angeles, CA

2d•Onsite

About The Position

In this vital role you will be part of a development and sustaining device engineering team that supports final product development of Electromechanical Device Platforms. You will be responsible for ensuring the product meets all requirements for safety, efficacy, and functionality through product lifecycle management. You will manage the creation and maintenance of design documentation in accordance with quality procedures. You will be part of multi-functional teams responsible for the development of drug-device combination products.

Requirements

Master’s degree
Bachelor’s degree and 2 years of Engineering and/or Operations experience
Associate’s degree and 6 years of Engineering and/or Operations experience
High school diploma / GED and 8 of Engineering and/or Operations experience

Nice To Haves

Bachelor's degree in engineering or other science-related field with 5+ years of relevant work experience with demonstrated ability in operations/manufacturing environment
Experience in medical device, pharmaceutical or a similar regulated industry
Background in development and commercialization of medical devices, and knowledge of manufacturing processes
Understanding of the following standards and regulations: Quality System Regulation – 21CFR820, Quality Management System for medical device/component manufacturers - ISO 13485, Risk Management for Medical Devices – ISO 14971
Excellent communication and technical writing sk

Responsibilities

Providing guidance on combination product and device design requirements and specifications
Leading product test strategies and execution to demonstrate product safety, performance, and efficacy
Manage combination product and device Design History Files
Analyzing data to support design acceptance, performance capability, and failure analysis
Creating and driving test protocols, methods, and reports
Transferring of technical information to manufacturing sites and support manufacturing scale-up and launches
Employ basic engineering skills and practices to gather user requirements and translate them into documentation
Engaging suppliers and development partners regarding specifications and quality levels
Provides authorship and expert technical leadership for regulatory filings
Managing project scope, schedule, and budget
Owns and support quality records, change records, and deviations
Supports device design complaint investigations and tracking to ensure timely resolution and continuous improvement
Collaborate with Process Development and external partners as a technical authority.