Description: • This is going to be an Amgen Thousand Oaks role and the EW will be working in several different buildings. At least 50% onsite for this role and this requirement will vary based on workload. Mon-Fri 8 AM - 5 PM. Need candidates that are local to the office. • Hiring Manager is ideally looking for candidates with a scientific background or engineering. Ideal candidate will have a background in a Biomedical, Chemical engineering or mechanical engineering. • Would be a plus if the candidates have experience regulated industry experience, biotech and pharma.
Top 3 Must Have Skill Sets:
1) Detail-oriented
2) Works well in teams
3) Education or experience related to working in a regulated industry (i.e. Medical, Aerospace, etc.)
Job Description
This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA, supporting senior staff in design, characterization, and qualification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.
This role will be required to: • Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments. • Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes). • Analyze and report data, along with any recommendations, to a variety of stakeholders. • Provide technical input for mechanical problems to programs as needed. • Plan and execute tolerance and robustness analysis of complex mechanical designs. • Use project planning and monitoring methods to ensure accurate completion. • Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle. • As part of the team working on device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.
Preferred/Demonstrated Competencies • Broad set of knowledge and expertise in contributing to 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 • Physical test method development, qualification, and validation • 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 • Technical understanding of drawings including tolerance stacks and robustness analysis • Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position • Familiarity 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), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601) • Knowledge of dFMEA/pFMEA • Capable of working on multiple projects in a deadline driven environment • Strong oral and written communication skills, decision making, presentation, and organization skills • Ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations • Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach • Track record of building or participating as a member of successful teams • Working knowledge of MS Office tools
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience