Sr. Engineer

Amgen has a long history of being committed and dedicated to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve lives.

Come join us!

The Senior device Engineer, Final Product Technology 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.

Experience in software development to support software requirements verification for electromechanical medical devices. Experience with production test software and tests methods to test finished medical devices. Develop software requirements, architecture, design, code, create test plans, debug software, troubleshoot issues that arise during development, develop innovative tools and methods to help improve life cycle management of devices in market.

The position will be dedicated to design/development engineering assignments focused on commercialized electro-mechanical systems, global technical compliance, and continuous improvements.

This opportunity is located in Thousand Oaks, CA.

Essential Skills and Responsibilities:

• 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

Basic Qualification:

• Doctorate degree, OR
• Masters degree and 3 years of directly related experience, Or
• Bachelors Degree and 5 years of directly related experience, Or
• Associates degree and 10 years of directly related experience

Preferred Qualifications:

• Masters degree in Mechanical/Electro-mechanical or Engineering and 5+ years of related engineering experience
• Medical device industry experience and regulated work environment experience
• Must have experience in software development for medical devices including troubleshooting.
• Experience with test system qualification (IQ/OQ/PQ) is highly desirable
• 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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

#Operations21

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.