Sr. Device Electrical Engineer
One Amgen Center Drive Thousand Oaks, CA 91320 | Contract
An electrical engineer who is a hands-on professional experienced with electronics in medical devices. The contract worker will be based in Thousand Oaks, CA and will report to the Director of Device Engineering, Electrical and Software Development.
The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
The contract Electrical Engineer will be primarily responsible for design, integration and testing of electrical and firmware subsystems for complex electromechanical drug delivery devices. The Engineer will be a member of a technical cross – functional team and will interface with key partners and external vendors to develop new drug delivery devices. As needed the Engineer will also be helping with development of detailed requirements, engineering specifications, verification & validation, and supporting regulatory submissions of these devices.
Travel: International and domestic travel of up to 25% might be essential. Key responsibilities include:
- Integrate firmware and electronics subsystems and manage interfaces and dependencies across the system.
- Perform characterization tests and generate reports.
- Participate in identifying test strategy and generating detailed test protocols. Perform formal verification and generate reports.
- Participate in requirements, risks and mitigations reviews, and ensure subsystem requirements meet system requirements and applicable quality and regulatory standards.
- Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
- 10+ years of experience in Medical Device/Combination Product development life cycle and knowledge of design control
- Experience with schematic capture and PCB layout tools such as Altium or OrCAD
- Experience in multilayers mixed signal PCB designs and EMI mitigation
- Strong hands-on skill on prototyping, board bring-up and troubleshooting down to component level
- Experience in low power microcontroller-based hardware and software designs
- Familiarity with lab instruments such as oscilloscope, logic analyzer, and battery testing equipment
- Familiar with the following standards: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use
- Travel domestically 50% first year; then 25% domestically will be essential