Glenn Sanders brings over 30 years of hands-on systems engineering experience in the design and development of complex medical instrumentation. He supports medical device OEMs and CMOs in delivering reliable, manufacturable, and regulatory-ready products by aligning system architecture, user needs, and risk management with production and compliance requirements. Glenn provides the foundational systems-level thinking that enables successful manufacturing and automation — including clear system architecture, rigorous requirements engineering, and comprehensive design documentation that supports downstream implementation and scale-up.

His fractional consulting services include:

• System architecture and requirements engineering – including use case analysis, user needs definition, and system-level requirements developed per INCOSE standards, with allocation to subsystems and full traceability to verification and validation.
• Design transfer readiness – creation of documentation and technical work products required for manufacturing and regulatory submission, including risk management aligned with ISO 14971 and support for V&V planning and execution.
• Cross-functional integration and program risk mitigation – coordinating across engineering, quality, regulatory, and operations teams, with a strong focus on early identification and mitigation of schedule and budget risks through rigorous risk register management.
• Experience across high-complexity devices – including hemodialysis machines, endoscope reprocessors, IVD detection systems, and ultra-low-flow sensors for drug delivery — projects requiring integration across hardware, software, human factors, and compliance domains.

Glenn works on a fractional basis with startups, mid-sized companies, and contract manufacturers seeking systems engineering expertise to accelerate development while ensuring compliance and manufacturability.