Engineer I - Los Angeles CA

What you will do

Let’s do this. Let’s change the world. 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.

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
• Managing 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
• Employing basic engineering skills and practices to gather user requirements and translate them into documentation
• Engaging suppliers and development partners regarding specifications and quality levels
• Authoring and expert technical leadership for regulatory filings
• Managing project scope, schedule, and budget
• Owning and supporting quality records, change records, and deviations
• Supporting device design complaint investigations and tracking to ensure timely resolution and continuous improvement
• Collaborating with Process Development and external partners as a technical authority

Minimum Education Required

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

Additional Qualifications/Responsibilities

• 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

Preferred Qualifications

• Excellent communication and technical writing skills

City

Los Angeles

State

California

Job Code

Pharmaceutical

Pharmaceutical Affiliate Sponsor

Amgen

Salary Range

>$100,000