Career CategoryOperationsJob DescriptionHOW 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 reach over 10 million patients worldwide. It's time for a career you can be proud of.

Principal Systems EngineerLive!What you will doLet's do this. Let's change the world. The Principal Systems Engineer will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture and lifecycle management. The PSE will work in collaboration with commercial, research, and process development leadership and colleagues to ensure developed product(s) meet the needs of users and meet performance per established requirements.

The PSE will lead creation and management of design inputs and outputs including user needs, system requirements, system architecture, and integration of subsystems through clinical entry, market entry, and lifecycle management. This will require ensuring robust systems approach and practices and robust system architecture across the interactions, dependencies, and interfaces of subsystems.The successful candidate will have demonstrated strength and success in managing interactions with key stakeholders and colleagues in the business.

Advance development of robust combination products/drug device combinations for global markets using best Systems Engineering principlesAdvance formal and ad-hoc technical and design reviews for the integrated systemSpearhead system definition in conformance to global regulatory guidance and best engineering methods including robust design inputs and outputs for clinical and market entryEnsure quality through integration of requirements, risks, and implemented mitigations through downstream design outputsDrive system verification and validation strategies across platform and brand-specific presentations.Own system performance & reliability targets and subsystem allocationsProvides authorship and expert technical leadership for regulatory filingsResponsible for mentoring, supervision, and directed professional development of more junior engineersWin!What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a leader with these qualifications.

Basic Qualifications:High School Diploma/GED and 12 years of Engineering experience ORAssociate's Degree and 10 years of Engineering experience ORBachelor's Degree and 8 years of Engineering experience ORMaster's Degree and 6 years of Engineering experience ORDoctorate Degree and 2 years of Engineering experiencePreferred Qualifications:Master's Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering10+ years of demonstrated success in medical device, drug delivery, or combination product/drug-device combination development for clinical entry and market lifecycle5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products/drug device combinations through product lifecyclePrior people management experienceDemonstrated product design and development success through product launch in major global regulatory regionsSuccessful experience managing multiple projects in a deadline driven environmentDemonstrated strength in development of user needs, market and system requirements, system and process verification and validation strategies, DOE/SPC/Risk Management methodsProficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and componentsStrong technical communications, both written and oral at different levels of the businessINCOSE certification or formal Systems Engineering training/certificationStrong understanding of injection molding, electronics fabrication, system assembly and manufacturing processesWorking knowledge of aseptic fill finish and controlled manufacturing environmentsDemonstrated success in platform product development with global multi-generation technology plansRobust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) conceptsProficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management softwareExperience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiativesFamiliar 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)Strong interpersonal skillsStrong oral and written communication skills.Thrive!What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insuranceA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and an annual site shutdownFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.

comAmgen 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 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 accommodation Salary Range143,568.00 USD - 166,488.

00 USDSummaryLocation: US - California - Thousand OaksType: Full time.