21 days old

Device Engineer, Final Product Technologies, Commercial Product Engineering

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    124219604
Amgen

Job ID: R-104833
Location: Thousand Oaks, CA, US

Amgen is now seeking an experienced Biomed/Pharma Device Engineer, Final Product Technologies, Commercial Product Engineering for our Thousand Oaks, CA facility. Our Device Engineer is a key part of our team that will focus on design development and lifecycle management related activities for commercialized drug delivery devices. These responsibilities include technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continuous improvement.

The Scope of this role includes mechanical and electro-mechanical delivery devices, such as; fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these medical industry devices are maintained. The medical device engineer will participate in cross 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 device engineer is responsible to apply all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and meaningful adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
  • Accountability of 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 or support system level root cause investigation, coordinate design improvements with development partners 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 position with leadership attributes to positively and efficiently 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.

Basic Qualifications:

Master's Degree

Or

Bachelor's Degree and 2 years of Engineering and/or Operations experience

Or

Associate's degree and 6 years of Engineering and/or Operations experience

Or

High school diploma/GED and 8 years of Engineering and/or Operations experience

Preferred Qualifications:

  • Master's degree in Mechanical/Electro-mechanical or Engineering and 5+ years of related engineering experience

  • Medical device industry experience and regulated work environment experience

  • 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

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.



PI124219604
Posted: 2020-10-01 Expires: 2020-11-02

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Device Engineer, Final Product Technologies, Commercial Product Engineering

Amgen
Thousand Oaks, CA 91360

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