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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Engineer – Mechanical Autoinjector Platform

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will participate in the design, development and lifecycle management related activities for commercial 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 delivery devices such as fluid transfer devices and automatic pen injectors. The qualified candidate will be part of a sustaining device engineering team that manages lifecycle and ensures design history files of the mechanical delivery devices are maintained. The engineer will participate in multi-functional teams leading device design activities such as analytical failure analysis, developing product enhancements, implementing design solutions, assessment of proposed changes, product launches, defending inspection, and follow through of commitments.

• Responsible for 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 tackle 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 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 optimally 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 self-starter with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree & 3 years of Engineering and/or Operations experience

Or

Bachelor’s degree & 5 years of Engineering and/or Operations experience

Or

Associate’s degree & 10 years of Engineering and/or Operations experience

Or

High school diploma / GED & 12 years of Engineering and/or Operations experience

Preferred Qualifications:

• Bachelor's degree in engineering or other science-related field with at least 7 years of experience in operations/manufacturing environment

• 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, so we 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 improve 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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.

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