Senior Mold Design Engineer

The Senior Mold Design Engineer is the primary authority for mold design, tooling strategy, process selection, and molding technology. This individual defines tooling concepts, recommends materials and equipment, develops scientifically sound validation strategies, and drives design-for-manufacturability decisions that enable reliable, scalable production.

Responsibilities

• Leads the design and development of precision injection molds for medical components, including insert molding, overmolding, multi-material, and other complex or tight tolerance applications.
• Translates customer and product requirements into manufacturable tooling concepts, mold specifications, acceptance criteria, and development plans; leads design-for-manufacturability and technical risk reviews.
• Develops and reviews 3D mold designs, detailed drawings, stack-ups, GD&T, gating, venting, cooling, ejection, steel-safe conditions, component selection, and maintainability provisions using SolidWorks or comparable CAD tools.
• Partners with Commercial, Estimating, and Program Management to define technical scope, tooling and equipment requirements, NRE, capital needs, schedules, piece-part cost assumptions, risks, and supplier deliverables for new opportunities.
• Provides technical direction to external mold builders and internal teams through design review, build, sampling, debug, acceptance, transfer, and production release; holds suppliers accountable for quality, timing, documentation, and performance.
• Leads or supports mold flow analysis, tool trials, process characterization, DOE, capability studies, and validation readiness; ensures tools and processes have robust operating windows before IQ/OQ/PQ and commercial launch.
• Diagnoses and resolves complex tooling, molding, equipment, and part quality issues using structured problem solving, data analysis, and hands-on collaboration with molding engineers, technicians, Quality, and Operations.
• Owns technical recommendations for mold repair, refurbishment, modification, spare components, preventive maintenance, capacity, obsolescence, and lifecycle management to improve uptime, yield, cycle time, and total cost.
• Evaluates and implements new tooling, molding, automation, and inspection technologies; develops equipment and tooling specifications and provides technical leadership for related capital projects.
• Establishes mold design standards, specifications, checklists, technical files, lessons learned, and training materials; mentors engineers, designers, toolmakers, and technicians to strengthen organizational capability and continuity.

Requirements

• 10+ years of progressive experience in injection mold design, mold engineering, toolmaking, tooling development, or advanced injection molding manufacturing, including ownership of tools from concept through production release.
• Demonstrated expertise in mold construction and function, including runner and gating strategies, venting, cooling, ejection, slides/lifters, inserts, hot runner systems, shrinkage, steel selection, tolerancing, and design for serviceability.
• Hands-on knowledge of injection molding processes, equipment, auxiliary systems, medical grade thermoplastics, and the interaction among part design, tool design, material behavior, process conditions, and equipment capability.
• Experience with insert molding and/or overmolding and the design of fixtures, inserts, loading methods, automation interfaces, or error-proofing features required for reliable production.
• Advanced proficiency in 3D CAD, preferably SolidWorks, and in creating or reviewing detailed manufacturing drawings, GD&T, tolerance analyses, bills of material, and controlled tooling documentation.
• Experience directing external mold builders, reviewing quotations and designs, conducting tool trials and acceptance activities, and resolving technical, schedule, cost, and quality issues.
• Ability to lead technical work through influence, communicate clearly with customers and cross-functional teams, document assumptions and decisions, and balance quality, manufacturability, cost, capacity, and schedule.

Preferred

• Experience in ISO 13485 regulated medical device manufacturing, including process validation, risk management, change control, and traceable engineering documentation.
• Working knowledge of mold flow analysis, scientific molding, DOE, SPC, process capability, measurement system analysis, test method validation, and IQ/OQ/PQ.
• Familiarity with CNC machining, EDM, grinding, additive manufacturing, mold maintenance and repair, automation, vision inspection, and tooling-related capital equipment qualification.
• Experience supporting customer-facing technical discussions, feasibility assessments, quotations, NRE and capital estimates, cost models, technology transfer, and early-production stabilization.