Amgen

Principal Systems Engineer

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 06, 2020
Ref
R-102781
Required Education
Bachelors Degree
Position Type
Full time

Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives?

Come join us!

We are seeking a Principal Systems Engineer (PSE) in our Systems Engineering group, located in Thousand Oaks, CA. This position will report to our Director of Systems Engineering & Risk Management.

In support of Amgen's mission to serve patients, the Systems Engineering group is a team with varied strengths working to identify, develop, commercialize and continuously improve devices in order to optimize the patient experience.

The PSE will lead intricate, multi-disciplinary and multi-functional product development efforts, facilitating the interactions, dependencies and interfaces across a set of subsystems. The successful candidate will lead technical teams towards the effective design, development, and transfer of drug delivery devices.

Part of the PSE's responsibilities includes being responsible for the entire front end of the development cycle, starting with identifying user needs, to translation into system requirements, developing the system architecture and allocation to subsystems. The PSE will also be leading the integration of the system components and orchestrating the verification and validation activities at a system level.

Assessing, tracking and mitigating technical risk is crucial to the success in this role. Thus, this individual will successfully interact with customers and vendors to facilitate the accurate design analyses and ensure customer satisfaction.

Responsibilities:

  • Leading process development efforts, striving for establishing Systems Engineering principles in combination product development cycle. Also leading System/Platform integration along with formal and ad-hoc technical and design reviews
  • Spearhead all user documentation as mandated by global regulatory agencies and engineering standard methodologies
  • Leading and being accountable for DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuring; also responsible for requirements breakdown to ensure quality and visibility.
  • Owning integration between requirements, risks, mitigation implementation downstream to design outputs.
  • Identifying & owning requirements including User Needs, System Design Input and Device Design input.
  • Leading/Driving verification testing strategy to include the differentiation between Platform and Combination Product testing to ensure minimum redundancy and maximum efficiency when executing against additional drug products.
  • Establishing system performance & reliability targets and allocations to components
  • Providing technical leadership for, and authorship of, regulatory filings; also providing direction and support for the efficient design of sophisticated, large scale systems through consideration of the system as a whole, rather than individual components of the system.
  • Providing technical coaching, mentoring and supervision to more junior engineers


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
Preferred Qualifications:

 

  • Master's Degree or PhD in Engineering, preferred Mechanical, Electrical, or BioMed
  • 10+ years of demonstrated and successful experience as an engineer or scientist within the appropriate field of study
  • 5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices; also experience in leading projects from development approval process.
  • Product design/development (design control) from concept to post product launch for Europe (EU MDR/CE Mark) & US submissions
  • Experience in drug/device combination product design and development
  • Capable of concurrently working on different projects in a deadline driven environment
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
  • INCOSE certification or formal Systems Engineering training/certification
  • Technical understanding of drawings and manufacturing processes (injection molding, assembly processes)
  • Proficient experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components
  • Demonstrated ability to partner with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product; also has broad exposure to HW/SW/Systems design and technical depth in one or more engineering fields (Electrical, Mechanical, Software, etc.)
  • Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams
  • Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance)
  • Experience in addressing and resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design trade-offs, tolerance/performance analysis, etc.
  • Robust knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
  • Proficient with Production Part Approval Process (PPAP) methodology
  • Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
  • Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts
  • Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
  • Strong interpersonal skills


Familiar with the following standards:

US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)

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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

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

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.