Amgen

Senior Engineer, Final Product Technology

Employer
Amgen
Location
Cambridge, MA, US
Posted
Oct 29, 2020
Ref
R-102530
Required Education
High School or equivalent
Position Type
Full time
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 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.

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 Cambridge, MA.

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 Master's degree & 3 years of Engineering and/or device development/manufacturing experience OR Bachelor's degree & 5 years of Engineering and/or device development/manufacturing experience OR Associate's degree & 10 years of Engineering and/or device development/manufacturing experience OR High school diploma / GED & 12 years of Engineering and/or device development/manufacturing experience

Preferred Qualifications:
  • A self-starter with proven leadership experience in leading multiple cross functional projects
  • Medical device industry experience and regulated work environment experience (FDA, OSHA, EPA, etc.)
  • Experience with combination product / medical device quality systems, proven design control experience is a must.
  • Strong experience in developing and commercialization of medical devices and knowledge of manufacturing processes.
  • Strong understanding and experience in system failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams are required.
  • Demonstrated strong communication and technical writing skills
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
  • This role requires up to 10% domestic and international travel


Amgen is committed 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.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.