Summary of Position

This position is responsible for the design, development, verification, and documentation of Class II medical device

hardware and software systems. The role requires hands-on experience with PCB development, embedded

software coding and assembly, and the creation of regulator-ready technical documentation. The position will

execute verification protocols and reports, interpret and apply standards such as IEC 60601-1, IEC 62304, and IEC

62366, and contribute to design control activities throughout the product lifecycle. The position also participates as

a technical lead during internal and external inspections/audits (i.e. FDA, EU MDR, UK MDR).

Primary Job Responsibilities

Primary job responsibilities include, but are not limited to:

• Participate in the development of new products and revisions to existing products in accordance with
• company design control procedures.
• Support electrical and software development activities, including PCB design reviews, prototype builds,
• debugging, and firmware implementation.
• Develop, execute, and document verification protocols, test methods, and reports with full traceability to
• requirements.
• Create and maintain Design Control documents including design plans, specifications, risk analyses,
• verification protocols, and reports.
• Interpret and apply requirements from IEC 60601-1 (electrical safety), IEC 62304 (software lifecycle), and
• IEC 62366 (usability engineering).
• Coordinate with internal and external resources, including third-party contractors, to support development
• activities.
• Participate in design reviews, risk reviews, and cross-functional technical discussions.
• Support manufacturing engineering during transfer-to-production, troubleshooting, and fixture
• development.
• Perform PCB-level troubleshooting using oscilloscopes, logic analyzers, and other diagnostic tools.
• Contribute to the Design History File (DHF), Device Master Record (DMR), and Risk Management File
• (RMF).

Accountability (size of responsibility)

• Ensuring compliance with Quality Management System requirements for Design Control and Risk
• Management.
• Coordination with Manufacturing, Quality Assurance, Regulatory Affairs, and other departments to
• support product development.
• Budget responsibility determined in concert with Sr Director and reported accordingly.

Qualifications

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related technical field with +10
• years of experience in Class II medical device product development or related engineering role.
• Hands-on experience with PCB design, assembly, debugging, and embedded software development.
• Demonstrated ability to create technical documents, verification protocols, and engineering reports.
• Experience with domestic and international medical device regulatory requirements; IEC 60601-1, IEC
• 62304, IEC 62366, and ISO 14971.
• Strong attention to detail with excellent written and verbal communication skills.
• Ability to interpret complex standards and translate them into engineering and product requirements.