Sr Engineer

Sr Mechanical Engineer- Device Engineering

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.

Basic Qualifications

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

Responsibilities:

• 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

Preferred Qualifications

• 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

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.

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.

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.