Amgen Sr Engineer in Thousand Oaks, California
Amgen is currently seeking a Senior Mechanical Engineer in our Device Engineering group to support technical teams in the successful design, development, testing, and transfer of drug delivery devices. The Senior Mechanical Engineer is an experienced mechanical design engineer possessing a broad knowledge set and expertise in complex, multi-disciplinary, cross-functional product design and development efforts. In support of Amgen’s mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize and continuously improve drug delivery devices in order to optimize the patient experience.
The Senior Engineer will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, Characterization and GMP Verification testing and will require a strong proficiency in developing test protocols, executing hands on testing, and reporting of results to senior leadership. This role will interface with customers and vendors to facilitate the proper planning and execution of design activities including CAD design, Testing, Tool/Fixture design and Methods development.
The person selected for this position will work closely with project team members to ensure that best practices are used in the execution of mechanical designs and in development of detailed engineering specifications. The person will perform device design and development, testing, analysis, modeling and design verification activities. The successful candidate may also participate in design transfer activities, test method development, and design control activities.
Doctorate degree and 2 years of Engineering experience OR
Master’s degree and 6 years of Engineering experience OR
Bachelor’s degree and 8 years of Engineering experience OR
Associate degree and 10 years of Engineering experience OR
High School diploma / GED and 12 years of Engineering experience
Provide complex mechanical design support to the mechanical engineering design organization
Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
Prepare and provide communications to leadership in support of recommendations and assessments
Verification testing strategy to include the differentiation between Platform and Combination Product testing to ensure minimum duplication and maximum efficiency when executing against additional programs
Ensure tests methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
Execute hands on testing of autoinjector devices, including the safe operation of test equipment
Collaborate with and support manufacturing sites on design/fabrication of assembly and labeling equipment
Perform solid modeling (SolidWorks) and create drawings using best practices in accordance with ANSI/ASME Y14.5 Geometric Dimensioning and Tolerancing Standard and Y14.100 Engineering Drawing Practices
Contribute to and/or lead execution of drug delivery design projects in different therapeutic areas, including nephrology, oncology, psoriasis, RA
Develop, execute, and review mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects
Assess product requirements to determine coverage of mechanical design
Provide technical assistance for mechanical problems to programs as needed
Evaluate alternative design concepts and perform trade-off analyses
Perform technical analyses and develop design solutions that will meet reliability targets and reliability allocations to components
Tolerance and robustness analysis of complex mechanical designs
Create and maintain design control documents
Develop and execute verification plans and procedures
Design with emphasis on DFM/DFA; with close collaboration and input from manufacturing team and other engineering groups
Master’s Degree in Engineering, preferred Mechanical, Electrical, or BioMed
6 or more years of progressive experience as an engineer within the medical device design field
3 or more years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III
Broad set of knowledge and expertise in leading complex, multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design and development
Background in development, commercialization, and lifecycle management of medical devices
Solid experience in documentation authoring from project start to end
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
Experience conceptualizing, designing and building test fixtures
Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)
Experience in injection molded plastic part design, molding process, 3D solid modeling and device assembly
Proficiency in FEA and SolidWorks 3D solid modeling of parts, large assemblies and advanced surface design
Technical understanding of drawings including tolerance stacks and robustness analysis
Proficiency with SAP PLM with SolidWorks integration for enterprise
Experience in leading projects from development approval process. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions
Leadership ability for Characterization, Verification and Validation testing of System and Subsystem Level Performance and Reliability characteristics
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), and Medical Electrical Equipment (EN 60601)
Strong background in documenting requirements and providing traceability documentation for FDA Approval – DOORS, Requisite Pro, or other similar requirements management software
Knowledge of dFMEA/pFMEA
Practical experience in configuration management and change control process/requirements – CCB (change control board), CIT (change implementation team) concepts
Demonstrated Design for Six Sigma competency
Strong communication and interpersonal skills
Strong problem solving, risk assessment, and risk management skills
Capable of working on multiple projects in a deadline driven environment
for a career that defies imagination
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Equal Opportunity Statement
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 a 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 an accommodation.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.