Sr Mechanical Platform Engineer

The Senior Platform Engineer is an experienced medical product design engineer with strong engineering project management background. The incumbent is required to have broad set of knowledge and expertise in leading complex and cross-functional commercialized platform improvement efforts. It is a technical role requiring the ability to develop and improve mechanical delivery systems 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 Engineer's responsibilities includes identifying user needs, to translation into system requirements, developing the system architecture and allocation to subsystems, and authoring related technical documentations. The Engineer is also responsible for managing the integration of the system components and orchestrating the verification and validation activities at system and sub-system level. Assessing, tracking and mitigating technical risk is a key element to the success in this role. The Engineer will interface with key partners and vendors to facilitate the proper design analyses and ensure customer satisfaction.

Responsibilities:

Discover and understand end-user requirements (patient, caregiver, etc.); translate user needs into system use cases and requirements Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs Develop and document 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 advanced computer simulations to design or test products.

Basic Qualifications:

Master's degree & 2 years OR Bachelor's degree or & 4 years OR Associate's degree & 8 years OR High school diploma / GED & 10 years of relevant experience

Preferred Qualifications:

• 5+ years of progressive experience as an engineer or scientist within the appropriate field of study. 3+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III.
• Demonstrated applied LEAN 6 Sigma competency.
• Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (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 documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software.
• Strength is engineering program management, communication and interpersonal skills, and ability to work in matrix team structures

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.