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Amgen, Inc.

Mechanical Engineer

Amgen, Inc. - Thousand Oaks, CA

Support project teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.Will support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.Responsibilities:Work cross-functionally with individuals and within project teams.Create and assess product requirements to determine technical coverage and proper integration of subsystems.Perform design analyses and assessments.Execute design characterization and design verification testing.Develop, execute, and review design documents, specifications, development plans, characterization plan, verification plans, reports, and other related product development documents for assigned projects.Provide technical assistance to projects.Basic QualificationsMaster\u2019s degreeORBachelor\u2019s degree and 2 years of Engineering experienceORAssociate\u2019s degree and 6 years of Engineering directlyORHigh school diploma \/ GED and 8 years of Engineering experiencePreferred QualificationsBachelor's degree in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 years experience with engineering processes and procedures.Participation in development projects from concept through the 510k and PMA approval process.Strong background in engineering of electro-mechanical and disposable medical devices.Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE\/SPC process optimization & validation (IQ, OQ, PQ), FMEA.Product design\/development (design control) from concept to post product launch for Europe (EMEA\/CE Mark) & US (FDA\/PMA\/510k) submissions.Experience in drug\/device combination product design and development.Familiarity with the following standards:21CFR820 Quality System RegulationAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.Strong problem solving, risk assessment, and risk management skills.Capable of working on multiple projects in a deadline driven environment.Solid works or other parametric solid modeler system experience.Plastic part design experience.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.

21 days 5 hours ago

Amgen, Inc.


Mechanical Engineer Amgen, Inc. - Thousand Oaks, CA, United States


Location: Thousand Oaks, CA

Company Profile:
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.