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For your reference, we have included the original job posting below.
Senior Engineer - Device Engineering
Job Number:
38272056
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Information Technology
Senior Engineer - Device Engineering
This position reports into the Device Delivery Engineering group in Thousand Oaks. This position will work with advanced and diverse engineering principles to execute the proper design, qualification and implementation of devices utilizing associated systems such as documentation, equipment and processes. The Senior Engineering must also leverage skills with device development, manufacturing and test equipment, injection molding, and material science to advance device development program for high volume consumable devices. In this position you will be expected to be able to execute tolerance analysis, stress analysis, and mold analysis of device components. Scope will include a wide range of products including; needle protection systems, autoinjectors, and reconstitution systems. Position will leverage organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.
Responsibilities -Support the technical execution of drug delivery projects. - Sustaining support for commercialized drug delivery projects. -Responsible for engineering aspects of the development and commercialization of drug delivery devices -Work cross-functionally with individuals and project teams in Operations to advance device programs at Amgen. -Work with Amgen's partners in the support of device, diagnostics, and ancillary items. .
Basic Qualifications • Doctorate degree OR • Master's degree & 3 years of directly related experience OR • Bachelor's degree & 5 years of directly related experience OR • Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
Preferred Qualifications MS in Mechanical Engineering, or other Engineering/Life Sciences 8 years of experience in engineering specific to the device or biotech/pharmaceutical industry. 2 years of experience with automated assembly equipment.
Demonstrated Competencies/Skills: -Strong background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired. -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.
- 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 Medical Electrical Equipment - EN 60601
-Industrial experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal). -Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. -General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. -Experience with partnerships between pharmaceutical and drug delivery companies. Independent thinker with demonstrated skills working in teams or leading project teams
