Senior Electrical Hardware Design Engineer

4 weeks ago

San Diego, United States Octet Medical, Inc. Full time

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.


Responsibilities

·        Lead and execute the design and development of complex electrical hardware systems for medical devices, including schematic capture, PCB layout, component selection, and bill of materials.

·        Conduct in-depth digital and analog electronic circuit design and integration, ensuring optimal functionality and adherence to design specifications.

·        Develop and implement comprehensive test plans for verification and validation of hardware designs, including prototype bring-up, debugging, and compliance testing.

·        Troubleshoot, modify and rework electronic circuits to optimize performance and address any identified issues.

·        Actively participate in the design control process, ensuring adherence to ISO 13485 quality management standards and regulatory requirements.

·        Create and maintain detailed technical documentation, including schematics, layouts, and test reports.

·        Collaborate effectively with internal teams (software, mechanical, quality) and external vendors to ensure seamless integration and project success.

·        Stay up-to-date on the latest advancements in medical device technology and relevant regulatory standards.

·        Other duties as assigned by management.


Preferred Experience

 

·        10+ years of experience in electrical hardware design for the medical device industry.

·        Proven track record of successfully leading and completing complex medical device design projects.

·        In-depth knowledge of digital and analog circuit design principles and troubleshooting techniques.

·        Experience with Design for Manufacturability (DFM) and Design for Test (DFT) principles.

·        Experience working in a highly regulated environment (ISO 13485) is a strong plus.

·        Strong understanding of regulatory requirements for medical devices (e.g., IEC 60601, FDA regulations).

·        Familiarity with risk management processes for medical devices (FMEA, FTA).

·        Experience working in a fast-paced, team-oriented environment.

·        Excellent communication, collaboration, and problem-solving skills.

·        Experience working with Altium Designer or similar advanced CAD systems.

·        Demonstrated ability to lead and mentor junior engineers.

 

Skills and Abilities

 

·        Proficient in printed circuit board design software (Altium Designer).

·        Hands-on direct working knowledge of oscilloscope, digital multimeter, soldering station equipment, and laboratory tools.

·        Strong understanding of electrical safety standards (IEC 60601) and regulatory requirements (ISO 13485).

·        Excellent written and verbal communication skills.

·        Ability to work independently and as part of a cross-functional team.

·        Highly organized and detail-oriented with a strong work ethic.

·        Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), MS Teams, and proficient in utilizing Gant charts for project management.

 

Job Requirements

 

Education/Experience

 

Bachelor's degree in Electrical Engineering, or a related field.

Proven experience using Altium Designer CAD software.

In-depth understanding of design control principles and ISO 13485 quality management system.

 

Job Complexity

 

Works on assignments that are complex where considerable judgment and initiative are required in resolving problems and making recommendations. 

 

Supervision

 

The Sr. Electrical Hardware Design Engineer reports to and is generally supervised by the Director of Engineering Services.


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