Director of Hardware Engineering

The Hardware Engineering Director provides strategic and technical leadership for the organization’s hardware engineering function, including electrical, embedded, mechanical, and electromechanical systems.

This role leads new product development and sustaining engineering for medical devices, ensuring teams deliver innovative, manufacturable, and compliant solutions in a regulated environment.

The successful candidate will be an experienced engineering leader with strong technical judgment, disciplined execution, and the ability to build, develop, and align high-performing teams across functions.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead, scale, and develop a multidisciplinary hardware engineering organization.
• Set clear priorities, assign resources, establish expectations, and evaluate performance to drive accountability and professional growth.
• Coach and mentor engineers and technicians to strengthen technical capability, leadership depth, and career development.
• Own end-to-end hardware project execution, from concept development, architecture, design, prototyping, verification, and validation through transfer to manufacturing.
• Drive new product development and sustaining engineering priorities across complex electromechanical medical device platforms.
• Review and approve engineering designs, tolerance analyses, test plans, risk assessments, and design documentation in accordance with medical device requirements.
• Provide technical leadership for the design and integration of mechanical, electrical, pneumatic, embedded, and software-enabled systems.
• Oversee prototyping, bench testing, design verification, validation, and technical problem-solving activities.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Partner with Product Management, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial teams to ensure feasibility, manufacturability, scalability, and market readiness.
• Communicate program status, technical risks, trade-offs, and mitigation plans clearly to executive leadership and cross-functional stakeholders.
• Establish engineering best practices, design standards, governance processes, and performance metrics that improve execution and decision-making.
• Identify and lead initiatives that improve product performance, quality, reliability, cost, and development efficiency.
• Perform other duties as assigned.

• Project/ Task Management
• Mechanical Skills
• Results Focus/ Output Orientation
• Team Orientation
• Interpersonal Communication
• Coaching/ Developing Others
• Leadership

Provides leadership and direct supervision for electrical, embedded, and mechanical engineering teams.

This role operates primarily in a professional office environment and routinely uses standard office equipment, including computers, phones, and photocopiers. Periodic time on the production floor is expected.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Very limited travel is expected, typically less than 5%.

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related engineering discipline required.
• 12+ years of progressive engineering experience, including design, development, and commercialization of complex hardware products.
• 5+ years of engineering leadership experience, including hiring, coaching, performance management, and organizational development.
• Demonstrated success leading multidisciplinary engineering teams across the full product development lifecycle, from concept through commercialization and sustaining engineering.
• Proven ability to build high-performing teams through coaching, mentoring, succession planning, and talent development.
• Experience establishing engineering processes, metrics, and organizational structures that improve execution, accountability, and cross-functional collaboration.
• Strong track record aligning engineering priorities with business objectives while balancing innovation,…