Senior Device Engineer - Combination Product Development and Lifecycle Management

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Device Engineer - Combination Product Development and Lifecycle Management in Combination Product Operations

Live

What you will do

Lets do this. Lets change the world. In this vital role the senior device engineer will participate in the design, development, and lifecycle management for clinical and commercial drug delivery devices. This includes technical operations supporting and leading design and development activities, design transfer to manufacturing sites, failure investigations, assessment of design changes, development of test procedures, scale-up and global launch, supplier relations, and support of continuous improvement activities.

The scope includes mechanical delivery devices including fluid transfer devices, prefilled syringes, and automatic pen injectors. The qualified candidate will be part of a development and sustaining device engineering team that supports final product development and ensures appropriate design documentation is established and maintained. You will participate in multi-functional teams, lead the creation of device design requirements, define and manage device testing, perform analytical failure analysis, implement design solutions, assess proposed design changes, prepare technical data to support regulatory filings, support design transfers and product launches, and support regulatory responses and inspections.

Essential skills and 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 new approaches to problems encountered.
• Developing and maintaining technical design records including but not limited to design input requirement, design specifications, verification protocols and reports, design transfer plans and reports prototyping
• Use statistically methods, such as DOE/SPC, to support product and process characterization
• Participate in Risk Management activities as a Subject Mater Expert
• Lead root cause investigations, coordinate design improvements with development partners, and lead implementation
• Collaborate with scientists and engineers, both internally and externally, to assess and develop appropriate design and manufacturing specifications and controls

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 Or
• Masters degree & 3 years of Engineering and/or Operations experience Or
• Bachelors degree & 5 years of Engineering and/or Operations experience Or
• Associates 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 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.

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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.