Job Purpose
The Senior Electrical Design Engineer is responsible for the design, development, and continuous improvement of electronic systems for critical care medical devices. This role supports the development of electronic hardware for both new and existing products, including printed circuit board (PCB) design, system architecture, wiring assemblies, and electro-mechanical integration, while ensuring compliance with applicable regulatory and quality standards.
Duties and Responsibilities
- Design, develop, integrate, and support electrical and electronic systems for complex medical devices throughout the product lifecycle.
- Contribute to system architecture, electrical design, subsystem integration, and technical requirements to support reliable and scalable product development.
- Provide technical leadership on assigned projects by supporting system integration, verification, validation, troubleshooting, and root cause investigations.
- Lead technical activities for assigned projects while collaborating with cross-functional teams, including Mechanical Engineering, Software Engineering, Quality, Regulatory Affairs, Manufacturing, and Technical Service.
- Prepare and maintain engineering documentation, including system requirements, electrical schematics, design specifications, test protocols, reports, and other technical documentation in accordance with engineering best practices.
- Perform engineering analyses, design trade-off evaluations, and risk assessments to support technical decisions and product performance.
- Mentor junior engineers and provide technical guidance to team members while promoting engineering best practices.
- Identify and implement continuous improvement opportunities related to product design, engineering processes, development tools, and workflow efficiency.
- Support design control activities, risk management, verification and validation testing, regulatory submissions, and compliance with applicable FDA, IEC, ISO, and Quality Management System requirements.
- Participate in design reviews, failure investigations, and field issue resolution to improve product quality, reliability, and customer satisfaction.
- Research and evaluate new technologies, components, and design approaches to support product enhancements and future development initiatives.
- Adhere to all company policies, procedures, quality standards, and business ethics requirements.
- Perform other duties as assigned.
Qualifications
Education and Experience
- Bachelor's degree in electrical engineering or a related engineering discipline required.
- Minimum of five (5) years of experience in electronic hardware design and development; experience with critical care or other Class II/III medical devices is preferred.
- Minimum of five (5) years of experience designing electronic circuits and printed circuit boards (PCBs) using electronic CAD software.
- Experience with FDA Design Controls, Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable IEC standards for medical device development.
- Experience supporting medical device development, including design verification and validation (V&V), risk management, and 510(k) submissions is preferred.
- Experience performing Design Failure Mode and Effects Analysis (DFMEA) and supporting product risk assessments.
- Experience supporting product transfer to manufacturing and sustaining engineering activities is preferred.
Skills & Abilities
- .Strong knowledge of electronic hardware design principles, schematic capture, PCB layout, circuit analysis, and troubleshooting.
- Working knowledge of FDA design documentation requirements, Design History Files (DHF), and engineering documentation for regulated medical devices.
- Ability to perform root cause analysis using structured problem-solving methodologies and recommend effective corrective actions.
- Strong analytical, organizational, and problem-solving skills with attention to detail.
- Excellent verbal, written, interpersonal, and technical documentation skills.
- Ability to manage multiple priorities and meet project deadlines in a fast-paced, cross-functional environment.
- Demonstrated ability to work independently while collaborating effectively with engineering, quality, manufacturing, regulatory, and service teams.
- Proficiency with Microsoft Office applications and electronic engineering design tools.
Compensation
The anticipated range for this position is $120,000 to $150,000 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.
Working Conditions
- The Senior Electrical Design Engineer usually works in an office environment which includes laboratory and manufacturing areas.
- The Senior Electrical Design Engineer works a standard work schedule and may need to extend hours as needed to meet company deliverables and deadlines.
Physical requirements
Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 30 lbs.
