Amgen

Device Engineer, Final Product Technologies, Commercial Product Engineering

Employer
Amgen
Location
Cambridge, MA, US
Posted
Nov 25, 2020
Ref
R-108286
Required Education
High School or equivalent
Position Type
Full time
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.

DEVICE ENGINEER, FINAL PRODUCT

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be part of the electro-mechanical OnBody injector platform team, participating in the device improvement, development, design transfer, and life-cycle management related activities for clinical and commercial drug delivery devices. This includes: technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement. Scope includes electro-mechanical delivery devices, such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems.

The position will be dedicated to design/development engineering assignments focused on commercialized electro-mechanical systems, global technical compliance, and continuous improvements. .
  • Fully proficient engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises innovative approaches to problems encountered.
  • Accountability for developing and maintaining technical records within design history file associated with assigned products
  • Developing Test Method, generating and maintaining design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
  • Lead system level root cause investigations, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
  • Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications
  • Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

At a minimum familiar with the following standards and regulation:
  • Quality System Regulation -21CFR820
  • Risk Management -ISO 14971
  • EU Medical Device requirements -Council Directive 93/42/EEC and new MDR regulations

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 team member with these qualifications.

Preferred Qualifications:
  • Master's degree in Mechanical/Electro-mechanical or Engineering and 5+ years of related engineering experience
  • Medical device industry experience and regulated work environment experience
  • A background in developing and commercialization of medical devices and knowledge of manufacturing processes
  • Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion
  • Familiar with the following standards and regulations: Quality System Regulation - 21CFR820
  • Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC
  • Ability to work independently and across functional teams
  • Excellent (technical) written and verbal communication

Basic Qualification:

Master's Degree
Or

Bachelor's Degree and 2 years of Engineering and/or Operations experience
Or

Associate's degree and 6 years of Engineering and/or Operations experience
Or

High school diploma/GED and 8 years of Engineering and/or Operations experience

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 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 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.

careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

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.