The Senior Electrical Engineer is a hands-on professional, experienced in the development of electronics in medical devices, responsible to lead all electrical design activities associated with all phases of product development, from concept and definition of requirements to system design architecture, definition of component specifications, component development, verification and validation testing, to product commercialization and sustaining. The Senior EE is responsible for stand-alone embedded system architecture and hardware development of medical devices, using microprocessor-based control systems, including but not limited to analog and digital circuit design, RF/EMI noise immunity, ESD protection, low power consumption systems, wireless applications, cost optimization, part selection, functional verification and testing, multi-layered board design, prototyping. PRIMARY DUTIES & RESPONSIBILITIES:
- Design development, integration and testing of electrical and firmware subsystems for complex electro-mechanicalmedical devices.
- Interface with key partners and external vendors as part of the technical cross-functional team developing detailed product requirements, engineering specifications, system architecture, detailed component specifications, verification and validation test protocols and reports, and supporting regulatory submissions of medical devices.
- Design, integrate and test microcontroller-based medical devices.
- Create electrical requirements, system architecture, design and test documentation. Integrate firmware and hardware.
- Design and validateassociated test equipment. Generate schematics, PCB layouts and BOMs.
- Integrate firmware and electronics subsystems and manage interfaces and dependencies across the system.
- Participate in identifying test strategy and generating detailed test protocols. Perform formal verification, and generate reports. Participate, review and approve outside lab test plans, protocols and reports.
- Participate in defining requirements, risks and mitigation 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, ensuring design and documentation traceability, and confirming that design outputs meet design inputs.
- Bachelordegree in Electrical Engineering.
- Master's degreepreferred.
- 7+ years of experience in Medical Device Product development life cycle and knowledge of design controls.
- Strong experience in embedded systems product development.
- Knowledge of electrical embedded systems and microprocessor controlled systems.
- Experience with system architecture design, schematic capture and PCB layout tools such as Altium or OrCad
- Experience in multilayer signal PCB designs and EMI mitigation
- Strong hands-on experience in prototyping and troubleshooting down to component level
- Experience in low-power microcontroller-based hardware and software design
- Familiarity with lab instruments such as oscilloscopes, logic analyzer, battery testing equipment
- Familiar with standards such as: 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
- Microcontroller experiencerequired; low voltageexperiencedesired.
- Familiar with a new product development process with experience to take a product from conceptual design phase to commercialization and post-market evaluation.
- Firmware / hardware integration.
- Strong interpersonal skills, mentorship skills, and time-management skills.
- Ability to communicate effectively across the enterprise, as well as various groups such as Regulatory, QA/QC, Supply Chain, internal customers (Marketing, Customer Service, Sales) and external suppliers.
- Very flexible and motivated.
- High level of commitment to the success of a project.
- Problem solving.
- Willing to travel abroad for small periods of time.
Kerr Corporation is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.