Description

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.

Requirements

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.

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