Senior Engineer - Device Platform – Combination Product Operations

Career Category

Job Description

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.

Senior Engineer - Device Platform – Combination Product Operations

What you will do

Let’s do this. Let’s change the world. In this role the Senior Engineering in Combination Product Development will lead the design, development, and lifecycle management of drug delivery drug/device combination products. This includes technical operations support for design control activities, contract manufacturing, failure investigations, leading and assessing design changes, developing test procedures, leading scale-up and global launch, developing supplier capabilities, and continuous improvement.

Key Responsibilities:

• Lead the multi-functional design and development teams in the final product development of prefilled syringe delivery systems, including packaging, labeling, and accessories
• Own product life-cycle management activities, supporting final product contract manufacturing and sterilization
• Lead product improvements, conduct analytical failure analysis, and implement design solutions
• Author technical records and ensure they are appropriately maintained in the design history file
• Lead system-level root cause investigations
• Work with scientists and engineers internally and externally to develop design and manufacturing specifications, verification and validation plans, protocols, and reports
• Author technical content in regulatory submissions
• Represent device engineering within a large network/matrix organization
• Evaluate test methods, prototype designs, and optimize products using DOE and statistical techniques
• Support contract terminal sterilization processes
• Monitor project progress, identify risks, and implement mitigation strategies to ensure project landmarks and timelines are met.
• Foster a collaborative and innovative team environment to drive continuous improvement and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree & 2 years of Engineering and/or Operations experience

OR

Bachelor’s degree & 4 years of Engineering and/or Operations experience

OR

Associate’s degree & 8 years of Engineering and/or Operations experience

OR

High School Diploma/GED & 10 years of Engineering and/or Operations experience

Preferred Qualifications:

• Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment
• Medical device industry experience and regulated work environment experience
• A background in developing and commercialization of medical devices and knowledge of manufacturing processes
• At a minimum familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC
• Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
• Excellent communication and technical writing skills
• Ability to work independently and across functional teams

Preferred Skills:

• Strong inter-personal and communication skills, with the ability to effectively collaborate with diverse teams and partners.
• Extensive knowledge of design controls and regulatory requirements for medical devices and combination products.
• Background in developing and commercializing medical devices and know