Amgen Senior Mechanical Engineer in Cambridge, Massachusetts

Amgen's Medical Device Development organization is looking for a Senior Mechanical Engineer to lead the technical teams towards the successful design, development, and transfer of drug delivery devices. Part of the Engineer's responsibilities includes owning the entire front end of the development cycle starting with identifying user needs, to translation into system requirements, developing the system architecture and allocation to subsystems. The Sr. Mechanical Engineer is also responsible for managing the integration of the system components and orchestrating the verification and validation activities at a system and subsystem level. Assessing, tracking and mitigating technical risk is a key element to the success in this role. The Engineer shall 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

Evaluate alternative system design concepts and perform trade-off analyses

Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs

Develop and document strong rational for testing strategy, acceptance criteria, and results

Work with Human Factors to ensure successful design validation from planning through report

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/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones

Conduct and review advanced computer simulations to design or test products

Up to 15% domestic/international

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Engineering experience

OR

Bachelor's degree and 5 years of Engineering experience

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

Broad set of knowledge and expertise in leading complex, multi-disciplinary and cross-functional product development efforts

Ability to develop complex electro-mechanical delivery system and sub-systems along with related interactions, dependencies and interfaces across a set of subsystems

Demonstrated Design for Six 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 injection molded plastic part design, molding process, 3D solid modeling and Small scale device assembly

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

Strong interpersonal skills

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.

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.