Amgen

Senior Manager of Engineering, Platform Technical Lead (Electro-mechanical Autoinjectors)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Dec 19, 2020
Ref
R-109896
Required Education
High School or equivalent
Position Type
Full time
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.

Senior Engineering Manager, Platform Technical Lead (Electro-mechanical Autoinjectors)

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 major contributor in a 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 field of platform delivery systems and technologies.

The Sr. Manager of Engineering , Platform Technical Lead (PTL) will be part of the electro-mechanical platform leadership team. This team is accountable for lifecycle management of electro-mechanical auto-injector and on body injector systems providing a crucial part of the Amgen combination product portfolio. The team also provides technical representation across multiple globally commercialized drug product teams.

The Sr. Engineering Manager will lead a team of device engineers that are responsible to assess, develop, and implement combination product related changes as well as manage technical documentation to ensure compliance throughout the lifecycle of commercialized products. This also includes development and implementation of innovative solutions to improve user experiences, as well as enabling new global product launches and variation management.

The position is located in Thousand Oaks, CA

Job Responsibilities:
  • Single point of technical accountability for the portfolio of final product presentation(s) for an electromechanical device platform within the Electro-Mechanical leadership team
  • Develop strategy and build Platform Portfolio Map to assemble lifecycle management plans to ensure supply, support product improvements, complaints, patient feedback, CAPA's, and strategic imperatives.
  • Partners closely with platform content lead, product delivery teams (PDTs), quality, complaints, and external supply chain teams
  • Ensures fit to platform for the design of new final products, drives decisions related to platform alignment and responsible for change impact evaluations.
  • Participates in platform governance meetings to present recommendations.
  • Ability to foster collaboration, work effectively on cross-functional teams, and proven ability to manage in a highly fluid, interactive, matrix environment
  • Engage in internal and external global network organizations and associated initiatives across Operations. Provide organizational and team mentorship for strategic business and compliance initiatives.
  • Develop a robust team and individual staff to grow into future leaders by developing, mentoring, and coaching.
  • 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 the following standards and regulations:
  • Quality System Regulation - 21CFR820Risk Management
  • ISO 14971EU Medical Device requirements
  • Council Directive 93/42/EEC


10% Domestic and International travel

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The engineering professional we seek is a collaborative team-player with these qualifications.

Preferred Qualifications:
  • Electro-Mechanical, System Engineering or equivalent engineering degree
  • 10+ years of medical device or Biotech industry experience and regulated work environment experience
  • 5+ years of experience in project leadership within a development environment, working with Medical Devices, ideally Class II and Class III
  • Strong background in development life cycle of medical devices through definition, development, verification, commercialization, and sustaining
  • Strong interpersonal skills and highly effective communicator with strong executive presence
  • 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
  • Experience in tech transfer, product manufacturing, and commercial scale up/global launch strategies Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601)

Basic Qualifications:

Doctorate degree and 2 years of engineering experience OR

Master's degree and 6 years of engineering experience OR

Bachelor's degree and 8 years of engineering experience OR

Associate's degree and 10 years of engineering experience OR

High school diploma / GED and 12 years of engineering experience

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.