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Leads technical execution and strategy for medical device product lines from concept through commercialization and sustaining engineering. Oversees multidisciplinary engineering teams, system architecture, requirements, design controls, prototyping, CAD, verification testing, risk management, design transfer, regulatory support, and manufacturing integration. Develops engineering talent and collaborates with clinical, regulatory, quality, manufacturing, marketing, and program management stakeholders to deliver compliant products aligned with customer and clinical needs.

Leads the Process Development Engineering function for medical device industrialization and commercialization. Responsibilities include manufacturing readiness, design transfer, process validation, manufacturing documentation, DMR approval, engineering change management, supplier and contract manufacturer collaboration, sustaining engineering, quality investigations, and regulatory compliance. The manager will recruit and lead a team of up to five engineers while establishing scalable processes and technical standards.

Own the corporate financial model and full P&L consolidation, including revenue, COGS, OPEX, cash flow, and balance sheet forecasts. Lead budgeting, forecasting, long-range planning, variance analysis, and financial reporting for executives and the board. Manage G&A, Clinical, and Medical Affairs planning, improve FP&A systems and processes, and support IPO and public-company readiness under U.S. GAAP and accrual accounting requirements.

Owns revenue, COGS, margin, and OPEX forecasting for Commercial, Operations, R&D, Facilities, IT, and Quality. Leads budgeting, long-range planning, variance analysis, business reviews, executive and Board reporting, and FP&A process improvements. Partners with senior leaders to explain financial drivers, address missed targets, and support IPO and public-company readiness under US GAAP and accrual accounting.