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Senior R&D Engineer (Electrical Engineering)
Sunnyvale
Summary of the Position
The Senior Electrical Engineer will develop and maintain components of the WiSE CRT System. Key responsibilities include contributing to hardware / system architecture and creating hardware requirements.
- Prototyping and modifying hardware designs, designing test PCBAs, and verifying designs and fixtures.
- Creating and maintaining design control documents (DHF, plans, protocols, reports, etc.).
- Establishing relationships with test labs, conducting testing, and troubleshooting issues.
- Leading projects individually or as part of a team, depending on project scale.
- Knowledge of standards and testing experience is required.
Essential Duties and Responsibilities
Manage implantable electrical hardware projects : Support design changes on the existing implantable and external devices. Design test fixtures to test our implantable devices for R&D, supplier, and manufacturing testing. Conduct feasibility and design verification testing of implantable devices. Establish relationships with test labs for standards testing and perform standards testing.Drive technical projects : Lead technical meetings, design reviews, and phase reviews.Create project schedules and plans : Manage project plans and the design history file (DHF).Collaborate across teams : Work with Quality, Regulatory, pre-clinical, Clinical, Marketing, and Engineering.Draft requirements : Define customer and design requirements, and methods for testing.Develop and trace requirements : Ensure design verification, manage requirements tracing, and conduct DHF gap analysis.Draft protocols and reports : Perform software and hardware V&V testing, tool validation, usability testing, and pre-clinical validation.Write manufacturing instructions : Develop test requirements, assembly and test instructions.Lead cross-functional collaborations : Focus on design and process risk management.Create development plans : Draft hardware development plans, design descriptions, and architecture.Other Duties and Responsibilities
Understand electrophysiology and solutions for cardiac pacing and heart failure.Learn about cardiac electrophysiology and clinical instruments used in the lab.Support complaints investigation, and corrective and preventative actions.Collaborate with Quality Assurance and Regulatory Affairs for accurate regulatory filings.Maintain a professional image with physicians, consultants, suppliers, and co-workers.Perform other duties as assigned.Education and Required Experience
BS in Electrical Engineering or MS in Electrical Engineering preferred.At least 7 years in the medical device industry, preferably with cardiac active implantable firmware and software design.At least 7 years as an electrical engineer leading board-level design / layout, and firmware (FW) development from design inception to post market support. ASIC and FPGA experience are a plus.Experience with implantable battery, implantable battery charger design, and battery testing is desired.Must have a strong understanding of electrical engineering principles and concepts.Must have strong hands-on skills to develop breadboards and test fixtures.Must be able to use Oscilloscope, Signal / Spectrum / Network / Logic / Impedance Analyzer, Signal Generator, Power Supplies, DMMs, DAQs, Data loggers, and other bench test equipment.Writing HW / FW technical protocols, reports, and performing V&V testing.Creating and managing requirements, trace matrices, and using requirements management tools.Leading project meetings, design reviews, phase reviews, and creating project schedules and meeting minutes.Familiarity with FDA 21 CFR 820, IEC-60601-1, IEC-62304, and IEC-62366-1 standards.Preferred experience with ISO-14708 and ISO-14117 standards.Interfacing with and managing standards test labs.Drafting development plans, design descriptions, and design architecture.Knowledge of design control processes per ISO-13485 and risk management per ISO-14971.Knowledge, Skills, and Abilities
Excellent communication and writing skills for collaboration.Strong time management and organizational skills.Proficiency with Altium, IAR IDE, Python scripting, Matlab programming, C / C , Microsoft Office, MS Project, MS Visio, Minitab preferred.Self-motivated, conscientious, and adaptable to multitasking in a fast-paced environment.Data-driven with strong analytical and problem-solving abilities.Proclivity to tinker and be hands-on, with a keen interest in exploring and solving technical challenges.Salary Range
157,000 - $212,000
Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.
About EBR Systems
Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.
EBR Systems offers a great place to work as well as generous benefits and growth opportunities :
Medical, dental, and vision insurance401KPTO – starting at 3 weeks per yearCompetitive salary with opportunities for career growthEmployee stock optionsLife insuranceWeekly company lunches and occasional happy hour eventsJ-18808-Ljbffr
Salary : $157,000 - $212,000
