Senior Systems Engineer

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Systems Engineer

What you will do

Let’s do this! Let’s change the world!

The Senior Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property and quality deliverables of a combination product (device/biologic combination) development program.

This role leads the capture of user needs and translation into system requirements and is also responsible for the functional decomposition and allocation to subsystems. The Senior Systems Engineer owns respective systems engineering deliverables and ensures that the quality targets are satisfied, identifies and communicates technical risks and coordinates risk retirement activities on the program. Also, maintains close cross-functional interaction within Amgen to deliver on customer satisfaction through high product quality.

Responsibilities:

• Provide leadership and support for requirements management for large or complex development programs.

• Lead the development, execution and review of requirements (within an electronic requirements management system), design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.

• Lead the creation and assessment of product requirements to determine technical coverage and proper integration different subsystems of combination products through consideration of the system as a whole, rather than individual components of the system.

• Work cross-functionally with individuals and project teams in Marketing, Operations, Manufacturing and Development.

• Oversight of characterization or feasibility testing as well as computer simulations.

• Utilize project planning and monitoring methods to ensure timely completion.

• Review and approve completed design documentation.

• Mentor junior engineers

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of directly related engineering experience OR

• Associate’s degree and 8 years of directly related engineering experience OR

• Bachelor’s degree and 4 years of directly related engineering experience OR

• Master’s degree and 2 years of directly related engineering experience OR

• Doctorate degree

Preferred Qualifications:

• 6+ years of progressive experience as an engineer within the appropriate field of study.

• 5+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination).

• Formal Systems Engineering training/certification.

• Demonstrated applied lean 6 Sigma competency.

• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.

• Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)

• Leadership ability for system-level design and testing (Verification and Validation testing of System Level Performance).

• 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:

• Needle-based Injection Systems – ISO 11608-1

• Prefilled Syringe Systems – ISO 11040

• Quality Management – ISO 13485

• Risk Management – ISO 14971

• EU Medical Device Regulation

• Strong background in documenting requirements and providing traceability documentation for regulatory approval – Dassault 3DS, DOORS or other similar electronic requirements management software.

• Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts.

• Strong interpersonal skills.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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. 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.