Senior Associate Scientist

Yoh has a contract opportunity for a SENIOR ASSOCIATE SCIENTIST to join our client in Thousand Oaks, CA.

JOB RESPONSIBILITIES:

Principal/Senior Mechanical Engineer, Drug Delivery Engineering:
- We are seeking a Mechanical Engineer at the Principal or Senior level.
- The successful candidate will operate within Amgen's Operations teams, interacting with global and cross-functional members from process engineering, device development, packaging, primary containers, and other groups.
- The position is within the device engineering group, part of drug delivery organization, that is responsible for development, transfer, and life cycle management of a wide range of drug delivery devices, such as; needle protection systems, fluid transfer systems, pen injectors, and automatic injectors.
- The Mechanical Engineer will work closely with team members and Principal Engineers to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices, and will manage portions of design transfer related activities, develop test methods, and support life cycle management of DHF items.
- The role of the Mechanical Engineer is to work within a cross-functional organization and provide technical expertise to support short-cycle robust device development.
- Create and maintain design control documents
- Assess product requirements to determine coverage of system mechanical hardware design.
- Execute to project plans and schedules -Develop, execute, and review mechanical hardware specifications, development plans, characterization plan, verification and validation plans and other related hardware development documents for assigned projects.
- Provide technical assistance for mechanical problems to other program as needed.

Job Qualifications:
- BS in Mechanical Engineering or equivalent and previous experience in a medical device industry
- Five (5) years current experience with engineering processes and procedures.
- Background in developing and commercialization of medical devices and knowledge of manufacturing processes.
- 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)visit our website to learn both about our company and about our leading workforce solutions.

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