30 days old

Principal Device Platform Engineer, Electromechanical Platforms

Amgen
Thousand Oaks, CA 91360
  • Job Code
    127608403
Amgen

Job ID: R-108682
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of.

Join us.

PRINCIPAL DEVICE PLATFORM ENGINEER

Live

What you will do

Let's do this. Let's change the world. In this exciting organizational and technical leadership opportunity, you will be a vital contributor in our high functioning worldwide Final Product Technologies (FPT) organization. As the Amgen commercial landscape continues to exponentially grow, the Commercial Advancement group, as part of FPT, expands to continuously develop, enable, and lead the current and future opportunities in the field of platform delivery systems and technologies.

The Principal Device Platform Engineer will be part of the Electromechanical platforms leadership team. This role is accountable for the strategy, process, and roadmap of technical content for the electromechanical platforms to enable rapid product implementation. This role is a critical part of the Amgen combination product portfolio and platform strategy.

The position is located in Thousand Oaks, CA

Job Responsibilities:
  • Single point of contact for electromechanical platform core technical content. Lead electromechanical platforms content strategy, set platform boundaries, and roadmap
  • Provide representation for device, container, secondary packaging, labeling, and human factors functions. Partners with commercial core content provider and operations core content Lead
  • Responsible for fit-to-platform and change impact evaluations, as well as development of product specific implementation strategies. Participates in platform governance meetings to present recommendations.
  • Partners with Platform Technical leads (PTL's), Final Product Technical Leads (FPT's), and SKU Technical leads (STL's)
  • Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver timely in a highly fluid, interactive, and matrix environment.
  • Responsible for content of platform design history folders (pDHF)
  • Develop lifecycle management plans for platforms in close coordination with product teams to support product improvements based on complaints, feedback, CAPA's, and strategic imperatives.
  • Engage in internal and external global network organizations and associated initiatives across Operations. Provide organizational and team mentorship for strategic business and compliance initiatives.
  • Conduct work utilizing Engineering judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devise innovative approaches to problems encountered.
  • Utilizes industry standards and regulations (Quality System Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC, etc.)
  • 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 engineering professional we seek is a collaborative leader with these qualifications.
  • Electro-Mechanical, System Engineering or equivalent engineering degree
  • 10+ years of medical device or Biotech industry experience and regulated work environment experience
  • Strong understanding and experience in bringing sophisticated regulated projects to timely conclusion and the ability to work independently with dynamic cross-functional teams
  • Strong background in development life cycle of medical devices through definition, development, verification, commercialization, and sustaining
  • Experience in applying best practices to the final product development process
  • Strong understanding of platform-based design, development, and verification
  • Excellent written and verbal communication skills
  • Ability to communicate effectively across the hierarchical chain; able to calibrate messaging to suit the specific audience
  • Outstanding ability to work in highly cross-functional teams, skilled at motivating people with different priorities and backgrounds to achieve a common goal
  • Analytical skills to interpret data and use independent judgment and discretion in developing solutions and making decisions for a variety of moderate and sophisticated issues


Basic Qualifications

Doctorate degree and 2 years of Engineering or lifecycle management in delivery systems

Or

Master's degree and 6 years of Engineering or lifecycle management in delivery systems

Or

Bachelor's degree and 8 years of Engineering or lifecycle management in delivery systems

Or

Associate's degree and 10 years of Engineering or lifecycle management in delivery systems

Or

High school diploma / GED and 12 years of Engineering of lifecycle management in delivery systems and 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or routing the allocation of resources

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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.



PI127608403

Categories

Posted: 2020-12-19 Expires: 2021-01-19

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Principal Device Platform Engineer, Electromechanical Platforms

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast