Description:
Key Responsibilities
"Design, develop, and test electronic circuits, systems, and subsystems for medical device products.
"Create and maintain engineering documentation, including schematics, specifications, test protocols, reports, and design history file documentation.
"Support all phases of product development, from concept generation through verification, validation, and commercialization.
"Develop and execute hardware verification and validation activities to demonstrate compliance with product requirements.
"Perform root cause analysis, troubleshooting, and corrective actions for design and manufacturing issues.
"Collaborate with Software, Mechanical, Systems, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure successful product development and launch.
"Support design reviews, risk management activities, and design control processes.
"Evaluate electronic components and technologies for suitability, reliability, manufacturability, and cost effectiveness.
"Support manufacturing transfers, process validations, and sustaining engineering activities.
"Contribute to continuous improvement initiatives related to product design, testing, and development processes.
Required Qualifications
"Bachelor's degree in electrical engineering, Electronics Engineering, Computer Engineering, or a related engineering discipline.
"3+ years of engineering experience in product development, testing, manufacturing, or a regulated industry (entry-level positions may consider internship or co-op experience).
"Strong understanding of analog and digital circuit design principles.
"Experience using laboratory equipment such as oscilloscopes, multimeters, logic analyzers, and power supplies.
"Ability to read and create electrical schematics and technical documentation.
"Strong analytical, problem-solving, and communication skills.
"Ability to effectively manage multiple priorities in a fast-paced environment.
Preferred Qualifications
"Experience in the medical device industry.
"Knowledge of Design Controls, Risk Management, Verification & Validation, and Quality System requirements.
"Experience designing embedded hardware, low-power electronics, battery-powered systems, or implantable medical device technologies.
"Familiarity with EMC/EMI, electrical safety, and regulatory standards such as IEC 60601.
"Experience with PCB design tools such as Altium, OrCAD, Cadence, or similar platforms.
"Knowledge of signal integrity, power management, and wireless communication technologies.
"Experience supporting manufacturing, process validation, and failure analysis activities.