Principal Engineer Systems Engineering

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Engineer Systems Engineering

What you will do

Lets do this. Lets change the world. In this vital role 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.

• Lead development of robust combination products / drug device combinations for global markets using best Systems Engineering principles
• Lead 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Doctorate degree and 2 years ofEngineering experience
OR
Masters degree and 4 years of Engineering experience
OR
Bachelors degree and 6 years of Engineering experience
OR
Associates degree and 10 years of Engineering experience
OR
High school diploma / GED and 12 years of Engineering experience

• Prior personnel management experience
• Masters 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
• 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)
• 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
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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, and flexible spending accounts.
• 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 bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.