Job Information
Amgen Principal Systems Engineer in Thousand Oaks, California
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 reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Principal Systems Engineer
Live!
What you will do
Let’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 principles
Advance formal and ad-hoc technical and design reviews for the integrated system
Spearhead system definition in conformance to global regulatory guidance and best engineering methods including robust design inputs and outputs for clinical and market entry
Ensure quality through integration of requirements, risks, and implemented mitigations through downstream design outputs
Drive system verification and validation strategies across platform and brand-specific presentations.
Own system performance & reliability targets and subsystem allocations
Provides authorship and expert technical leadership for regulatory filings
Responsible for mentoring, supervision, and directed professional development of more junior engineers
Win!
What we expect of you
We 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 OR
Associate’s Degree and 10 years of Engineering experience OR
Bachelor’s Degree and 8 years of Engineering experience OR
Master’s Degree and 6 years of Engineering experience OR
Doctorate Degree and 2 years of Engineering experience
Preferred Qualifications:
Master’s Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering
10+ years of demonstrated success in medical device, drug delivery, or combination product / drug-device combination development for clinical entry and market lifecycle
5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products / drug device combinations through product lifecycle
Prior people management experience
Demonstrated product design and development success through product launch in major global regulatory regions
Successful experience managing multiple projects in a deadline driven environment
Demonstrated strength in development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods
Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components
Strong technical communications, both written and oral at different levels of the business
INCOSE certification or formal Systems Engineering training/certification
Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes
Working knowledge of aseptic fill finish and controlled manufacturing environments
Demonstrated success in platform product development with global multi-generation technology plans
Robust 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) concepts
Proficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
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)
Strong interpersonal skills
Strong oral and written communication skills.
Thrive!
What you can expect of us
As 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 insurance
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown
Flexible work models, including remote work arrangements, where possible
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
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 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.