Sr. Device Electrical Engineer

Location: Thousand Oaks, CA
Date Posted: 03-23-2018
Day to Day Responsibilities:
Design, integrate, and test microcontroller-based combination product.
Author requirements, design, and test documentation.
Integrate firmware and hardware.
Design and validate associated test equipment.
Generate schematics, PCB layouts, and BOMS.

Note:
Travel domestically 50% first year; then 25% domestically will be essential

Summary:
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.

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.

Preferred Qualifications
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

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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