Senior Systems Engineer
| Company | Amgen |
|---|---|
| Location | Cambridge, MA, USA, Thousand Oaks, CA, USA |
| Salary | $119195 – $147867 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- 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
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
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