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For your reference, we have included the original job posting below.
Principal Engineer - Drug Delivery
Job Number:
38272071
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Science & Biotech
Principal Engineer - Drug Delivery
Successful candidate will lead 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. The qualified candidate will lead technical teams to ensure successful device development of these high volume consumable components. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support validation and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Position Responsibilities • Oversight and execution of drug delivery projects in the nephrology/oncology therapeutic areas. • Global oversight responsibilities of device related project at Amgen sites. • Responsible for engineering aspects of the development and commercialization of drug delivery devices/systems and novel formulations for macromolecules. • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development and serve as a primary contact with Amgen's external drug delivery partners. • Work with Amgen's partners in the support of device, diagnostics, and ancillary items.
Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master's degree & 6 years of directly related experience OR • Bachelor's degree & 8 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 • BS in Engineering and previous experience in a medical device industry • 10 years current experience with engineering processes and procedures. • Led projects from development through the 510k and PMA approval process. • Familiarity with lean manufacturing and six-sigma methodology. • Strong background in engineering and commercialization of injectable devices. • 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: o US Good Manufacturing Practices - 21CFR820 o Quality Management - ISO 13485 o Risk Management - ISO 14971 o EU Medical Device requirements - Council Directive 93/42/EEC o Medical Electrical Equipment - EN 60601
• Small scale device assembly experience. • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. • Strong problem solving, risk assessment, and risk management skills. • Must be capable of working on multiple projects in a deadline driven environment. Must have strong oral and written communication skills, decision making, presentation and organization skills.
