Engineer - Mechanical Autoinjector Platform

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

EngineerMechanical Auto-injector Platform

Live

What you will do

Lets do this. Lets change the world. In this dynamic role you will participate in the design, development and lifecycle management of drug delivery devices and combination products. This includes technical operations support for design control activities, failure investigation, leading and assessing design changes, development of test procedures, scale-up, global launch, supplier development, contract manufacturing, and continuous improvement.

Scope includes mechanical injection systems such as fluid transfer devices and automatic pen injectors. The qualified candidate will be part of a device engineering team that manages lifecycle and maintains design history files of the mechanical delivery devices and combination products. The engineer will participate in multi-functional teams to support activities such as analytical failure analysis, developing product improvements, implementing design solutions, assessment of proposed changes, product launches, defending inspection, and follow through of commitments. Responsibilities include:

• Applying all conventional aspects of the subject matter, functional area, and assignments. Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria, and devise innovative ways to solve problems.
• Accountability of developing and maintaining technical records within design history file associated with assigned products.
• Develop test method, generate and maintain design specification. Responsible for protocol and report writing, prototyping, DOE/SPC, product optimization, design verification and validation, FMEA, etc.
• Lead or support system level root cause investigation, coordinate design improvements with development partners, problem solving, critical thinking, and implementation of design changes and improvements.
• Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Individual contributor with Leadership attributes to effectively represent Platform Device Engineering within a large network and matrix organization.

Win

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 a collaborative partner with these qualifications.

Basic Qualifications:

• Masters degree OR
• Bachelors degree & 2 years of Engineering experience OR
• Associates degree & 6 years of Engineering experience OR
• High school diploma / GED & 8 years of Engineering experience

Preferred Qualifications:

• Master's degree in engineering and 3+ years of industry experience
• Bachelor's degree in engineering and 5+ years of industry experience
• Experience in drug delivery, preferable combination product; or medical device industry and regulated work environment
• Background in development 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 sophisticated projects to conclusion
• Excellent communication and technical writing skills
• Ability to work independently and across functional teams

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.