Principal Systems Engineer

Amgen - Thousand Oaks, CA4.1

Full-time
Amgen is currently seeking a Principal Systems Engineer in our Final Product Technologies (FTP) group. This position will report to our Director of Systems Engineering. In support of Amgen’s mission to serve patients, the FTP group at Amgen is a diverse team working to identify, develop, commercialize and continuously improve drug delivery devices to optimize the patient experience.

The Principal Systems Engineer will lead complex, multi-disciplinary and cross-functional product development efforts, managing the interactions, dependencies and interfaces across a set of subsystems. The successful candidate will lead technical teams towards the successful design, development & transfer of drug delivery devices. Part of the Principal Systems Engineer’s responsibilities includes owning 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 Principal Systems Engineer is also responsible for managing the integration of the system components and orchestrating the verification and validation activities at a system level. This Principal Systems Engineer will also lead the reliability engineering for early design and development of devices and device platforms. Assessing, tracking and mitigating technical risk is a key element to the success in this role. This role will interface with customers and vendors to facilitate the proper design analyses and ensure customer satisfaction.

Responsibilities:
Lead technical project teams, managing risk, resources, cost, and schedule for the technical deliverables Discover and understand end-user requirements (patient, caregiver, etc.)
Translate user needs into system requirements
Develop system requirements for compliance to standards
Develop system use cases
Evaluate alternative system design concepts and perform trade-off analyses
Flow-down system requirements to sub-systems/components
Establish system performance & reliability targets and allocations to components
Develop and execute system verification and validation plans & procedures
Manage technical risk (quantify, monitor, mitigate, report, etc.)
Provide technical leadership for regulatory filings
Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system.
Provide technical coaching and mentoring to more junior engineers
Reliability Engineering

Define reliability attributes and make recommendations for implementation
Conduct analysis of reliability problems and investigate field returns to determine root causes and develop plans for short and long-term reliability improvement
Determine the cost advantages of alternatives and developing action plans to comply with industry standards to meet business needs
Lead a small team of reliability engineers and technicians
Establish and manage a reliability lab
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 progressive 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, ideally Class II and Class III
5+ years of experience with defining and executing reliability plans for medical devices of relatively complex electrical and/or mechanical designs
Experience in leading projects from development approval process. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions
Experience in drug/device combination product design and development
Strong problem solving, risk assessment, and risk management skills
Capable of working on multiple projects in a deadline driven environment
Strong background in developing, commercialization, and lifecycle management of medical devices
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
Demonstrated applied Six Sigma competency, including DFSS
Creative problem-solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program
INCOSE certification or formal Systems Engineering training/certification
Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components
Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product
Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (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 resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.
Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
Familiar with the following standards: (1) US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); (2) Needle-based Injection Systems (ISO 11608-1); (3) Quality Management (ISO 13485); (4) Risk Management (ISO 14971); (5) EU Medical Device requirements (Council Directive 93/42/EEC); (6) Medical Electrical Equipment (EN 60601)
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
Amgen focuses on areas of high unmet medical need and leverages 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.

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.

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.

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.