FPT Principal Device Engineer
The Principal Device Engineer is an experienced professional product design engineer with a broad set of knowledge and expertise in leading sophisticated, multi-disciplinary and multi-functional product development efforts. It is a highly technical role requiring the ability to develop mechanical and electro-mechanical delivery system and sub-systems along with related interactions, dependencies and interfaces across a set of subsystems. S/he will lead technical teams towards the successful design, development, and transfer of drug delivery devices. Part of the Principal Engineer's responsibilities includes leading the architecture of combination products starting with identifying user needs, to translation into system requirements, developing the system architecture and allocation to subsystems. The Engineer is also responsible for owning the integration of the system components and orchestrating the verification and validation activities at system and sub-system level. Assessing, supervising and mitigating technical risk is a key element to the success in this role. The Engineer will work with key partners and vendors to facilitate the accurate design analyses and ensure customer satisfaction.
- Discover and understand end-user requirements (patient, caregiver, etc.); translate user needs into system use cases and requirements
- Lead design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs
- Develop and detail robust tracing from design inputs through design outputs, verification, and validation
- Generate, review, and/or approve protocols, reports, and other DHF documentation ensuring robust documentation for regulatory agency submission
- Work with manufacturing and development teams on design transfer plans through execution
- Ensure compliance of Regulatory and Quality requirements across platforms and related technical dossier
- Conduct and review sophisticated computer simulations to craft or test products.
Basic Qualifications: Doctorate degree and 2 years of product design engineering experience
Master's degree and 6 years of product design engineering experience
Bachelor's degree and 8 years of product design engineering experience
Associate's degree and 10 years of product design engineering experience
High school diploma / GED and 12 years of product design engineering experience
- 15+ years of dynamic 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.
- Proven applied LEAN 6 Sigma proficiency.
- Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering fields (Electrical, Mechanical, Software, etc.)
- Experience in model-based design and UML and Small scale device assembly experience.
- Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance).
- 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 detailing requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.
- Strong interpersonal skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.