Senior Engineer – Electrical/Microcontroller Medical Devices (JP4975)
Thousand Oaks, CA.
Device Engineering - Electrical and Software Development
1+ years (likely extensions)
3Key Consulting Inc. is recruiting for a Senior Electrical Engineer
with 7+ years’ experience in electrical engineering and 5+ years in medical device/combination device experience, and expertise in microcontrollers, low voltage and firmware/hardware integration for a global, CA-based, bio-pharmaceutical company.
Amgen is searching for a contract Electrical Engineer who will be a technical hands-on professional experienced with electronics in medical devices. The Electrical Engineer 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 and analysis of low power electrical hardware, 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 developing detailed requirements, engineering specifications, verification & validation, and supporting regulatory submissions of these devices. International and domestic travel of up to 25% might be essential. Key responsibilities include:
Top Must-Have Skill Sets:
- Integrate firmware and electronics subsystems and manage interfaces and dependencies across the system.
- Perform circuit design, simulation, analysis and PCB layout. Must have 3+ years of experience using Altium for PCB design.
- Perform battery testing and power budgeting.
- Perform in 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.
Day to Day Responsibilities
- Microcontroller experience.
- Need low voltage experience.
- Medical device development process.
- Firmware/hardware integration.
- 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.
Master's Degree and 3 years of Electrical or Computer Engineering experience
Bachelor's Degree and 5 years of Electrical or Computer Engineering experience
Associate's degree and 10 years of Electrical or Computer Engineering experience
High school diploma/GED and 12 years of Electrical or Computer Engineering experience
Why This Position Is Open:
- 5+ years of experience in Medical Device/Combination Product development life cycle and knowledge of design control.
- Experience in multilayers mixed signal PCB designs and EMI mitigation.
- Experience in PCBA automated testing.
- 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
New project that needs additional support.
Employee Value Proposition:
Too many short term positions, no longevity in previous roles.
Phone then in-person interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.