Description

**HOW MIGHT YOU DEFY IMAGINATION?**

You’ve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

**Senior Device Engineer – Combination Product Development and Lifecycle Management in Combination Product Operations**

**Live**

**What you will do**

Let’s do this. Let’s change the world. In this vital role, the senior device engineer will participate in the design, development and lifecycle management related activities for commercial drug delivery devices. This includes technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, development test procedures, scale-up and global launch, supplier development, and continuous improvement.

Scope includes mechanical delivery devices such as, prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of the mechanical devices are maintained. The engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

**Responsibilities:**

+ The Senior Device Engineer will be responsible for applying all conventional aspects of the subject matter, functional area, and assignments. This individual will 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 problems encountered.

+ Accountability of developing and maintaining technical records within design history file associated with assigned products.

+ Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.

+ Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and implementation 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.

+ This position will be located in Thousand Oaks, CA or Cambridge, MA and requires up to 10% domestic and international travel.

**Win**

**What we expect of you**

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

**Basic Qualifications:**

+ Doctorate degree by time of hire OR

+ Master’s degree by time of hire & 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 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment

+ Experience in medical device industry and regulated work environment

+ Background in development and commercialization of medical devices, and knowledge of manufacturing processes

+ Understanding of the following standards and regulations:

+ Quality System Regulation – 21CFR820

+ Quality Management System for medical device/component manufacturers – ISO 13485 Risk Management for Medical Devices – ISO 14971

+ EU Medical Device Regulation – 2017/745

+ Strong understanding and experience in design controls, failure investigation, initiating and bringing complex 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 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.

**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.

Share on LinkedInShare on FacebookShare on Google+Pin on PinterestEmail this to someone