Duties and Responsibilities:
- Defines and drives the long-term strategy for the Company's hardware platforms, including
mechanical, electrical, firmware, and device-level subsystem evolution.
- Owns senior-level accountability for hardware platform architecture, system integration, validation, manufacturing readiness, and field quality outcomes.
- Leads the Hardware Management team and associated engineering staff to ensure coordinated execution across mechanical, electrical, and firmware disciplines.
- Leads validation and QA leadership to ensure effective product verification, validation, reliability testing, and release readiness.
- Ensures that product requirements from individuals at the Product Management level are translated into executable engineering strategies and production-ready device platforms.
- Drives alignment between product intent, hardware architecture, engineering execution, and manufacturing outcomes.
- Establishes and maintains clear operating models, decision boundaries, and escalation paths across Engineering, Validation, Product Management, and Manufacturing.
- Ensures device-level integration across hardware, firmware, accessories, operating environments, and supporting system dependencies.
- Owns overall validation strategy and quality expectations for hardware platforms, including design verification, system validation, reliability, and root-cause oriented quality improvement.
Education and Experience:
- Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering field is required.
- 10+ years of progressive engineering experience in hardware, systems, or regulated product development environments is required.
- 7+ years of leadership experience managing engineering, validation, quality, or related technical teams is required.
- Experience with product validation, reliability, quality systems, and regulated development environments is required.
- Experience in medical device, assistive technology, or other compliance-driven product environments is preferred.
Required Skills and Abilities:
- Strong senior leadership capability with demonstrated ability to lead leaders and build high performing technical organizations.
- Deep expertise in hardware systems, mechanical engineering, electrical design, firmware integration, system validation, and device readiness.
- Strong understanding of the full product development lifecycle, including design controls, validation, manufacturing transfer, quality, and sustainment.
- Ability to align product strategy, engineering execution, validation rigor, and operational realities into coherent, executable plans.
- Strong systems thinking, problem-solving, and technical judgment across multi-disciplinary product environments.
- Excellent communication, collaboration, and influence skills across executive, technical, product, quality, and operations audiences.
- Ability to make high-quality decisions under complexity, balancing customer value, risk, timelines, cost, and compliance requirements.
- Strong organizational and financial management capabilities, including planning,
prioritization, budgeting, and resource allocation.
- Commitment to quality, accountability, operational excellence, and continuous improvement.
