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.
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.