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Leads strategic customer accounts for a medical device contract manufacturer, serving as executive liaison and customer advocate. Owns account growth, revenue, profitability, retention, forecasting, commercial negotiations, and contract renewals. Coordinates cross-functional teams across operations, engineering, quality, supply chain, finance, and product development to resolve complex issues and deliver customer commitments. Develops account strategies, leads executive reviews, manages risks, supports quality and operational initiatives, and mentors account management staff.

Develops and validates manufacturing processes for complex medical-device catheters. Responsibilities include designing process parameters, tooling, fixtures, and semi-automated equipment; conducting DOE and statistical process studies; executing IQ/OQ/PQ validation; leading product introductions and process improvements; preparing engineering documentation; supporting quality investigations; and mentoring engineers.

Develops, optimizes, validates, and transfers surface processes for Nitinol medical devices, including microblasting, chemical etching, polishing, electropolishing, and cleaning. Uses statistical analysis, DOE, Lean, Six Sigma, root-cause investigation, and process data analysis to improve performance. Supports manufacturing transfer, validation, documentation, training, troubleshooting, and continuous improvement while collaborating with engineering, quality, manufacturing, and production teams.

Develops, optimizes, validates, and transfers thermomechanical manufacturing processes for Nitinol medical devices. Responsibilities include designing precision fixtures and tooling, developing heat treatment and forming processes, conducting DOE and statistical analysis, investigating root causes, analyzing process data, supporting validation and manufacturing transfer, creating technical documentation, and driving continuous improvement. The role collaborates with manufacturing, quality, engineering, and operations teams while managing multiple technical priorities independently.

Works on moderate-scope quality engineering problems and projects, analyzing situations and data, supporting equipment and task decisions, implementing design changes, and developing solutions to limited-scope issues. May handle broad assignments and provide technical guidance to lower-level personnel.

Leads complex, cross-functional customer and internal programs from concept through commercialization. Responsibilities include developing integrated plans, managing scope, schedule, resources, budgets, risks, quality, and dependencies; leading governance and Stage Gate reviews; presenting executive updates; resolving conflicts; influencing teams without direct authority; and ensuring regulatory, quality, customer, and financial objectives are achieved across multiple functions and sites.

The Senior Staff Process Development Engineer oversees manufacturing line design, capacity analysis, and process validation while leading cross-site initiatives and mentoring junior engineers.

The role involves developing textile-based medical structures, leading technical projects, and collaborating with teams for process improvement and validation. Hands-on work is required along with writing SOPs and managing multiple projects.

The Staff Quality Engineer ensures compliance to standards in medical device projects, supporting product development and manufacturing through quality assurance practices, statistical analysis, and risk management.

Manage day-to-day facility and office operations for the Laguna Niguel site, including vendor and landlord relationships, supplies and procurement, onboarding support, facilities maintenance and calibration tracking, basic IT and office moves, customer order processing, and reporting site metrics to senior management. Acts as first point of contact and backup for Customer Solutions, improving processes and ensuring invoices and payments are handled timely.