Head of Hardware Engineering - Medical Devices

Confidential Careers; Minneapolis, Saint Paul (MN, MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Confidential Careers seeks a seasoned Hardware Engineering Director to lead electrical, embedded, mechanical, and electromechanical systems for medical devices. This leader will drive design, verification, validation, and transfer to manufacturing while ensuring compliance with stringent regulatory standards.

You will align cross-functional teams, coach talent, and establish best practices to improve execution, quality, and cost performance across programs.

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Biomedical, or Systems Engineering.
• 12+ years of progressive engineering experience including hardware product development.
• 5+ years of engineering leadership including hiring, coaching, and org development.
• Proven ability to lead multidisciplinary teams through full product lifecycle.

Responsibilities

• Lead and scale a multidisciplinary hardware engineering organization.
• Set priorities, allocate resources, and drive performance and growth.
• Coach engineers and technicians to strengthen technical capability and leadership.
• Own end-to-end hardware project execution from concept to manufacturing transfer.
• Drive new product development and sustaining engineering of complex devices.
• Review designs, test plans, risk analyses, and documentation per medical device requirements.
• Provide technical leadership for mechanical, electrical, embedded, and software-enabled systems.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Partner with Product Management, Manufacturing, Quality, Regulatory, and Supply Chain.

Skills

Leadership

Cross-functional

Hardware design

Regulatory knowledge

Architecture reviews

Education

Bachelor’s in Electrical/Mechanical/Biomedical or Systems Eng

Master’s degree (preferred)

Job description

Confidential Careers seeks a seasoned Hardware Engineering Director to lead electrical, embedded, mechanical, and electromechanical systems for medical devices. This leader will drive design, verification, validation, and transfer to manufacturing while ensuring compliance with stringent regulatory standards.

You will align cross-functional teams, coach talent, and establish best practices to improve execution, quality, and cost performance across programs.