Design Engineer

POSITION SUMMARY: 

The Design Engineer is responsible for supporting the design, development, and manufacturing implementation of molded components, tooling, fixtures, and related processes. This position works closely with customers, Engineering, Quality, and Operations to translate customer requirements into manufacturable solutions.

DUTIES AND RESPONSIBILITIES (essential functions of position): 

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. For assigned area and products:

• Design and develop components, tooling, molds, fixtures, and manufacturing solutions for silicone insert molding and transfer/compression molding applications.
• Review customer drawings, models, specifications, and requirements to determine manufacturability and identify potential design or process concerns.
• Provide Design for Manufacturability (DFM) recommendations to customers and internal teams.
• Develop and maintain 3D CAD models, engineering drawings, specifications, and other technical documentation.
• Support the design and development of molds and tooling used in silicone molding processes.
• Work closely with customers and Business Development during new product development and quoting activities to develop technically sound manufacturing solutions.
• Partner with Operations to ensure designs and tooling are practical, repeatable, and aligned with shop-floor capabilities.
• Support new product introduction from initial design through prototype, validation, and production launch.
• Participate in tooling trials, process development, troubleshooting, and optimization activities.
• Assist with the development and execution of engineering studies, process validations, and qualification activities.
• Identify opportunities to improve product design, tooling, cycle time, material utilization, quality, and overall manufacturing efficiency.
• Lead or support root cause investigations and corrective actions related to design, tooling, and manufacturing issues.
• Collaborate with Quality to ensure designs and processes meet customer specifications and applicable medical-device quality requirements.
• Manage engineering projects, priorities, timelines, and deliverables while communicating project status to internal and external stakeholders.
• Maintain accurate engineering documentation and support engineering change control processes.
• Work directly with tooling suppliers, material suppliers, and other external partners as needed.
• Support continuous improvement initiatives throughout the manufacturing operation.
• Provide technical support and guidance to production team members during product launches and ongoing manufacturing.
• Perform other duties and engineering projects as assigned.

ESSENTIAL EDUCATION, SKILLS, EXPERIENCE AND QUALIFICATIONS:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Product Design Engineering, or a related technical field preferred.
• Previous experience in a manufacturing, product design, tooling, or process engineering environment preferred.
• Experience with silicone molding, insert molding, transfer molding, compression molding, injection molding, or similar manufacturing processes strongly preferred.
• Ability to communicate effectively with customers, suppliers, production employees, and leadership.
• Ability to manage multiple projects and priorities in a fast-paced manufacturing environment.

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):

• Experience with silicone molding, insert molding, transfer molding, compression molding, injection molding, or similar manufacturing processes strongly preferred.
• Experience designing molds, tooling, fixtures, or manufacturing equipment is a plus.
• Proficiency with 3D CAD software and the ability to create and interpret detailed engineering drawings.
• Strong understanding of GD&T, tolerance analysis, materials, and manufacturing processes.
• Experience working in medical device, orthopedic, or other regulated manufacturing environments preferred.
• Knowledge of ISO 13485 and medical-device quality requirements is a plus.