**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.
**What you will do**
Let’s do this. Let’s change the world. In this pivotal role, you will interact with global and multi-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups.
+ Author design control and technical documents, including test/verification plans, test protocols, test reports, engineering assessments, design outputs, and technical recommendations
+ Hands-on testing of auto-injector devices, including the safe operation of test equipment and devices containing sharps (syringes)
+ Develop a verification testing strategy to include differentiation between platform and combination product testing to ensure minimum duplication and maximum efficiency when commercializing multiple programs
+ Ensure tests methods and test protocols are developed in a sound and robust framework with a high focus on eliminating test errors
+ Prepare and provide communications to leadership in support of recommendations and assessments.
+ Collaborate with and support manufacturing sites on design/fabrication of assembly and labeling equipment
+ Provide complex mechanical design support to the mechanical engineering design organization.
+ Conceptualize, design, and manufacture robust, accurate, and precise test fixtures to support test activities
+ Familiarity with solid modeling (SolidWorks) and mechanical drawings using standard methodologies in accordance with ANSI/ASME Y14.5 Geometric Dimensioning and Tolerancing Standard and Y14.100 Engineering Drawing Practices
+ Supply to and/or lead the implementation of drug delivery design projects in different therapeutic areas, including nephrology, oncology, psoriasis, RA
+ Develop, implement, and review mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects.
+ Provide technical feedback for mechanical problems to programs as needed.
+ Tolerance and robustness analysis of complex mechanical designs
+ Design with emphasis on DFM/DFA; with close collaboration and guidance from the manufacturing team and other engineering groups
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients.
+ Master’s degree OR
+ Bachelor’s degree and 2 years of experience OR
+ Associate’s degree and 6 years of OR
+ High school diploma / GED and 8 years of experience
+ Bachelor’s Degree in Engineering, preferred Mechanical, Electrical, or BioMed
+ 1 or more years of experience as an engineer within the medical device design field
+ 1 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 contributing to complex, multi-disciplinary and multi-functional product development efforts
+ Experience in drug/device combination product design and development
+ Background in development, commercialization, and lifecycle management of medical devices
+ Experience with material & test specification generation, protocol/report authorship, process, and test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
+ Experience implementing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
+ Experience conceptualizing, designing, and building test fixtures
+ Experience in injection molded plastic part design, molding process, 3D solid modeling, and device assembly
+ Experience 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
+ 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)
+ 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
+ Capable of working on different projects in a fast-paced environment
**Some of the vast rewards of working here**
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.
+ Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
+ A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
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.
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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.