Senior Device Engineer, Combination Product Operations, Commercial Product Engineering

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.

Live

What you will do

Lets do this. Lets 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. The Senior Engineer is an experienced medical product design engineer with strong engineering project management background. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement. Assessing, tracking and mitigating technical risk is a key element to the success in this role. The Senior Engineer will collaborate with key partners and vendors to facilitate the proper design analyses and ensure customer satisfaction.

Scope includes mechanical and electro-mechanical delivery devices, such as: fluid transfer devices, automatic pen injectors, reusable automatic injectors, or micro-infuser delivery pump systems. The qualified candidate will be part of a development and sustaining device engineering team that ensures design history files of these systems are maintained. The engineer will participate in multi-functional teams, leading device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Responsibilities:

• Apply all conventional aspects of the subject matter, functional area, and their assignments; plans and conducts work requiring judgment in the independent evaluation, selection, and meaningful adaptation and modification of standard engineering techniques, procedures and criteria; and devises new approaches to problems encountered.

• Accountable for maintaining technical records within design history file associated with assigned products.

• Support system level design, development, and V&V work for commercial lifecycle management changes or in support of new project development

• Develop test methods, generate and maintain design specifications, 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, tactical 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

• Performs as an individual contributor with leadership attributes to optimally represent device engineering within a large network/matrix organization

The position is located in Thousand Oaks, CA 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 employee with these qualifications.

Basic Qualifications:

Doctorate Degree

Or

Masters Degree and 3 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment

Or

Bachelors Degree and 5 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment

Or

Associates degree and 10 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment

Or

High school diploma/GED and 12 years of Engineering and/or Operations experience within a cGMP manufacturing environment/ OR within a biotech or medical device manufacturing environment

Preferred Qualifications:

• Masters degree in biomedical/mechanical/electrical or related Engineering field and 7+ years of related engineering experience

• Progressive experience as an engineer or scientist in project leadership within a development or research, operations and manufacturing environment, working with Medical Devices, ideally Class II and Class III.

• Medical device industry experience and regulated work environment experience

• A background in development and commercialization of medical devices and knowledge of manufacturing processes

• Systems Engineering design experience and thinking, being able to drive user needs to design requirements to verified and validated final product outputs

• 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, Quality Management (ISO 13485), 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

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 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.