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!

Responsibilities:

• Analyze problems involving cross-disciplinary aspects of the product development process, and synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to tackle complex engineering problems

• Provide direction and support for the optimal design of complex, large-scale systems through consideration of the system as a whole, rather than individual elements of the system

• Provide leadership in the initial conceptualization of the design of a system, define and document the requirements of the system to ensure it meets user and stakeholder needs.

• Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality

• Oversee the integration of components and subsystems to endure they work together to achieve the overall system requirements.

• Identify and resolve technical issues arising during development and testing phases across the broad span of mechanical, software, hardware, and electrical/electronic subsystems.

• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program achievement

• Contribute to the multifunctional team in areas of supplier management, contract testing laboratories, Human Factors design, Risk Management, and both pilot and commercial production manufacturing processes.

• Conduct and review advanced computer simulations to design or test products

• Prepare cost and resource estimates on proposed major design products

• Provide technical presentation support and consultation to marketing

• Use project planning and monitoring methods to ensure accurate and timely completion

• Originate and communicate concepts that could lead to new products

• Review and approve completed design work

• Actively contributes to identifying and pursuing new technological opportunities

This position is located in either Thousand Oaks, CA or Cambridge, MA, and involves up to 10% domestic and international travel

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 Engineering and/or device development/manufacturing experience OR

• Associate’s degree and 8 years of Engineering and/or device development/manufacturing experience OR

• Bachelor’s degree and 4 years of Engineering and/or device development/manufacturing experience OR

• Master’s degree and 2 years of Engineering and/or device development/manufacturing experience OR

• Doctorate degree

Preferred Qualifications:

• 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

• INCOSE certification or formal Systems Engineering training/certification

• Demonstrated applied lean 6 Sigma competency

• Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components

• Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place, and current

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

• Demonstrated skills in eagerly identifying, facilitating, and driving closure of a product/program

• 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 subject areas (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 leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)

• 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:

• US Good Manufacturing Practices – 21CFR820

• Quality Management – ISO 13485

• Risk Management – ISO 14971

• EU Medical Device requirements – Council Directive 93/42/EEC

• Medical Electrical Equipment – EN 60601

• Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS, 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

• Strong verbal and written communication 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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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.