Senior Mold Design Engineer

Biomerics; Winston-Salem (NC); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Medical Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Job summary

Biomerics is seeking an experienced Senior Mold Design Engineer to lead complex injection mold programs for medical components, with emphasis on insert molding, overmolding, and tight-tolerance applications.

This technical lead defines tooling concepts, selects materials, and drives design-for-manufacturability from customer engagement through manufacturing launch. Collaboration with Commercial, Estimating, and Program Management ensures accurate NRE estimates and schedules.

Qualifications

• 10+ years of progressive experience in injection mold design, mold engineering, toolmaking, tooling development, or advanced injection molding manufacturing.
• Hands-on knowledge of injection molding processes, equipment, and materials used in medical devices.
• Experience with insert molding and overmolding and related fixtures, loading methods, or automation interfaces.

Responsibilities

• Leads the design and development of precision injection molds for medical components, including insert molding and tight tolerance applications.
• Translates requirements into tooling concepts, mold specs, acceptance criteria, and development plans; leads design-for-manufacturability reviews.
• Develops 3D mold designs, drawings, GD&T, gating, venting, cooling, ejection, and tooling documentation using SolidWorks.
• Defines technical scope with Commercial, Estimating, and Program Management; outlines NRE, capital needs, schedules, and costs for new opportunities.
• Provides direction to external mold builders and internal teams through design, build, sampling, debug, transfer, and production release; manages supplier performance.
• Leads mold flow analysis, DOE, process characterization, validation readiness; ensures robust operating windows before IQ/OQ/PQ and launch.
• Diagnoses and resolves tooling, molding, and part quality issues through data analysis and cross-functional collaboration.
• Owns recommendations for mold repair, refurbishment, and lifecycle management to improve uptime and cost.
• Evaluates new tooling, molding, and inspection technologies; leads related capital projects.
• Establishes mold design standards, checklists, and training materials; mentors engineers and technicians.

Skills

Mold design

Mold engineering

3D CAD

SolidWorks

GD&T

Troubleshooting

Cross-functional leadership

Tools

SolidWorks

Job description

Description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Job Description

We are seeking an experienced Senior Mold Design Engineer to serve as the technical lead for complex injection molding programs, with a focus on insert molding, overmolding, and tight-tolerance applications. This role provides technical leadership from initial customer engagement and estimating through development, validation, technology transfer, and commercial launch.

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. The role works directly with customers and cross-functional teams to turn challenging product concepts into robust manufacturing solutions.

Working closely with Commercial, Estimating, Program Management, Quality, Manufacturing, Supply Chain, and Operations, the Senior Mold Design Engineer ensures project scope, technical risk assessments, non-recurring engineering (NRE) estimates, piece part costs, schedules, and technical deliverables are accurate, achievable, and aligned with customer requirements.

Beyond project execution, this individual establishes mold design standards, drives engineering best practices, mentor's technical talent, and strengthens organizational capability in tooling and molding. They are expected to expand technical expertise across the business and elevate the overall performance of the molding organization.

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.

Biomerics offers the following benefits:

Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.