IoT Hardware Design Engineer for Regulated Medical Devices

Promega Corporation; Fitchburg (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Terso seeks an experienced hardware design engineer to develop IoT devices from concept to production, focusing on performance, reliability and manufacturability. You will produce CAD models, schematics, BOMs and build protocols while coordinating with firmware, QA, and cross-functional teams.

The role involves prototyping, testing, and validation to ensure regulatory and safety requirements are met, with opportunities to implement AI/automation tools and contribute to future medical device

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years in product design for IoT hardware.
• Proficiency in SolidWorks for models, assemblies and drawings.
• Experience with design-for-manufacturing and regulatory considerations.
• Ability to collaborate across engineering disciplines and QA.

Responsibilities

• Participate in mechanical and electromechanical design from concept to production with focus on performance and reliability.
• Develop detailed engineering documentation including CAD models, wiring schematics, BOMs, build protocols.
• Plan and execute hardware prototyping, testing, and validation to meet timelines.
• Perform design iterations and risk mitigation for manufacturability and assembly.
• Coordinate testing and experiments to verify assumptions, performance, and safety.
• Support hardware integration with cloud/connectivity modules and regulatory alignment.
• Assist with hardware certification and compliance processes for FCC/CE/ISO and future FDA standards.
• Collaborate with firmware, QA and cross-functional teams for seamless integration.
• Contribute to risk management and traceability under medical device lifecycle standards.
• Maintain orderly design revision records and lessons learned for knowledge sharing.

Skills

Product design

IoT hardware

Regulatory awareness

DFM

Electromechanical systems

Cross-functional collaboration

Technical communication

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

Terso seeks an experienced hardware design engineer to develop IoT devices from concept to production, focusing on performance, reliability and manufacturability. You will produce CAD models, schematics, BOMs and build protocols while coordinating with firmware, QA, and cross-functional teams.

The role involves prototyping, testing, and validation to ensure regulatory and safety requirements are met, with opportunities to implement AI/automation tools and contribute to future medical device