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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 proficient – preferably Solidworks

• Strong interpersonal skills

• Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position

• Familiar with the following standards:

US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (Council Directive 93/42/EEC); Medical Electrical Equipment (EN 60601)

• Competent in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.