Senior Engineer, Injection Molding Expert

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, Injection Molding Expert

What you will do

Let’s do this. Let’s change the world. In this vital role you will participate in a technical team towards the successful design, development, and transfer of drug delivery devices. The successful candidate will be responsible for overseeing the injection molding processes, ensuring the production of high-quality medical device components from our manufacturing sites. This role requires a deep understanding of injection molding techniques, materials science, and regulatory requirements. Key Responsibilities:

• Injection Molding Process Management: Execute and optimize injection molding processes to ensure high-quality components production at manufacturing sites. A focus area will be on tooling qualifications. Knowledge of DOE and use of statistics will be critical.
• Tooling and Equipment: represent Amgen during the design, selection, and maintenance of injection molding tools and equipment.
• Material Selection: Work with cross-functional teams to select appropriate materials for injection molding applications where applicable.
• Engineering Testing: Responsible for engineering test protocol, execution & report writing, process & test development, prototyping, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Quality Assurance: Implement and require manufacturing sites follow quality control measures to ensure compliance with design specifications and regulatory requirements.
• Documentation: Create and maintain detailed documentation, including design transfer plans, risk management files, and design history files.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and successful design transfer.
• Troubleshooting: Identify and resolve issues related to injection molding processes, tools, and materials.
• Continuous Improvement: Identify opportunities for process improvements and implement best practices to enhance efficiency and effectiveness.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience; OR
• Associate’s degree and 8 years of Engineering experience; Or
• Bachelor’s degree and 4 years of Engineering experience; Or
• Master’s degree and 2 years of Engineering experience; Or
• Doctorate degree

Preferred Qualifications:

• 6-8 years of progressive experience as an engineer or scientist in relevant fields (medical device development, manufacturing, etc.)
• 7+ years of Molding experience in a development, research, or manufacturing environment, ideally with Mold tools for medical devices (Class II and Class III)
• Solid experience in Mold tooling manufacturing and development processes, including experience working under Design Controls
• Proficiency in Design for Manufacturing (DfM) and Design for Assembly (DfA)
• Strong analytical skills and experience with structured problem-solving approaches
• Proficiency in materials science, particularly polymers and metals used in medical devices
• Excellent communication and presentation skills
• Ability to work within cross-functional and cross-cultural teams
• Extensive device development competences within:
• Design of components for injection molding
• Dimensioning and tolerancing of injection molded components
• Materials science (especially polymers)
• DFM/DFA
• Strong physics/mathematics background
• CAD