One Amgen Center Drive Thousand Oaks, California 91320 | Contract
TOP 3 SKILL SETS:
1. Injectable device
2. Complaint handling
3. Design control
Support the development and sustaining 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 support technical teams to ensure successful development and sustaining of these mechanical medical devices. The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, clinical manufacturing, and post launch complaint handling activities of these devices. The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support the robust of the device development and manufacturing.
- Create and execute to technical protocols and prepare technical reports to support development and commercialization of the combination products.
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Work with quality engineers and complaint managers to take care of device complaint handling and assessment including root cause analysis with tight timeline requirement
- BS in Engineering and previous experience in a medical device industry
- 5 years current experience with engineering processes and procedures.
- Supported projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of mechanical medical 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/US
- Experience in drug/device combination product design and development
- Familiar with the following standards:
- o Quality System Regulation – 21CFR820
- o Risk Management – ISO 14971
- o Needle based injection system – ISO -11608, FDA guidance on pen, injectors o EU Medical Device requirements – Council Directive 93/42/EEC
- 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.
VERY IMPORTANT NOTE: Qualified candidates with a strong Mechanical or System Engineering background, need apply and will be considered!!!