Senior System Engineer
Full Time
Thousand Oaks, CA 91362
$111,913 - $132,048 a year
Posted Just posted
Job description
Career Category
Engineering
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Systems Engineer
Live
What you will do
Let’s do this! Let’s change the world!
The senior systems engineer advances combination product programs by defining the user needs & design input requirements, collaborating with a cross-functional team to identify technical solutions and reviews technical documents supporting the design history file for a program. The successful candidate establishes well-supported insights for concept and development stage solutions to serve the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. This role ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Responsibilities:
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Analyze problems involving cross-disciplinary aspects of the product development process and synthesize multiple solutions.
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Develop structured, efficient approaches to analysis and design to tackle complex engineering problems.
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Provide direction and support for the optimal design of complex systems through consideration of the system as a whole, rather than individual elements of the system.
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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.
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Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program achievement.
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Provide technical presentation support and consultation to marketing.
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Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs.
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Produce innovative technical solutions to customers.
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Develop potential applications to exploit new business opportunities.
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Collect and analyze information on competitor product performance.
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Use project planning and monitoring methods to ensure accurate completion.
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Originate and communicate concepts that could lead to new products.
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Review and approve completed design work.
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Actively contributes to identifying and pursuing new technological opportunities.
Familiar with the following standards:
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US Good Manufacturing Practices – 21CFR820
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Quality Management – ISO 13485
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Risk Management – ISO 14971
Win
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 employee with these qualifications.
Basic Qualifications:
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Doctorate degree OR
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Master’s degree and 3 years of Engineering and/or device development/manufacturing experience OR
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Bachelor’s degree and 5 years of Engineering and/or device development/manufacturing experience OR
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Associate’s degree and 10 years of Engineering and/or device development/manufacturing experience OR
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High School diploma/GED and 12 years of Engineering and/or device development/manufacturing experience
Preferred Qualifications:
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10+ years of progressive experience as an engineer or scientist within the appropriate field of Study.
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5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III.
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INCOSE certification or formal Systems Engineering training/certification.
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Strong background in documenting requirements and providing traceability documentation for
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FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
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Practical experience in configuration management and change control process/requirements –
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CCB (change control board), CIT (change implementation team) concepts
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Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
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Demonstrated applied lean 6 Sigma competency.
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Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components.
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Demonstrated experience with NPIs, ISO regulatory compliance process and design history files
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Creative problem solver and solution developer when presented with conflicting requirements, business demands, and technical risks/issues.
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Demonstrated skills in eagerly identifying, facilitating, and driving closure of a product/program.
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Demonstrated ability to work with technical leadership team to implement product.
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Platform/subsystem multi-generation technology plan for a specific release of a global program/product
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Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering subject areas (Electrical, Mechanical, Software, etc.).
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Experience in model-based design and UML and Small scale device assembly experience.
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Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams.
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Leadership ability for System Level Design and Testing (Verification and Validation testing of System-Level Performance).
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Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis).
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Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc.
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Deep knowledge of Quality Management System, Quality Management Policy, and applicable laws and regulations as they apply to this job type/position.
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Strong interpersonal 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.
The annual base salary range for this opportunity in the U.S. is $111,913 - $132,048.
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:
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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.
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A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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Stock-based long-term incentives
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Award-winning time-off plans and bi-annual company-wide shutdowns
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Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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Salary Range
111,913.00 USD - 132,048.00 USD
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