Sr Engineer - PFS Platform and Lyo Kit

Amgen Inc. • Thousand Oaks, CA

38d

About The Position

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Engineer - PFS Platform and Lyo Kit 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, ensuring the product meets all requirements for safety, efficacy, and functionality, and product lifecycle management. They manage the creation and maintenance of design documentation in accordance with quality procedures. They will be part of multi-functional teams responsible for the development of drug-device combination products. This position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.

Requirements

• High school diploma / GED and 10 years of Engineering and/or Operations experience OR
• Associate's degree and 8 years of Engineering and/or Operations experience OR
• Bachelor's degree and 4 years of Engineering and/or Operations experience OR
• Master's degree and 2 years of Engineering and/or Operations experience OR
• Doctorate degree

Nice To Haves

• Bachelor's degree in engineering or other science-related field with 7+ 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
• EU Medical Device Regulation - 2017/745
• Excellent communication and technical writing skills

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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees