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For your reference, we have included the original job posting below.
Engineer - Device Engineering
Job Number:
42442091
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Science & Biotech
Engineer - Device Engineering
This position reports into the Drug Delivery Systems (DDS) group under Global Drug Product and Device Development in Thousand Oaks. This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of devices, diagnostics and ancillary items utilizing associated systems such as documentation, equipment and processes. Knowledge of device development, manufacturing and test equipment, injection molding, and material science is important to the position.
The position requires excellent 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. This position is should also have the following experiences:
1. 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. 2. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. 3. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. 4. 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). 5. Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired. 6. General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired. 7. Experience with partnerships between pharmaceutical and drug delivery companies.
Basic Qualifications • Master's degree OR • Bachelor's degree & 2 years of directly related experience OR • Associate's degree & 6 years of directly related experience OR • High school diploma / GED & 8 years of directly related experience
Preferred Qualifications Advanced degree in Mechanical Engineering, or other Engineering/Life Sciences 3 years of experience in engineering specific to the device or biotech/pharmaceutical industry. 3 years experience with device design, production and validation
Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams or leading project teams 2) Strong Interpersonal and communication skills
