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.
