Job Title: Product Engineer - Incontinence Pad Medical Device

Location:  Louisville, KY

Department:  Engineering

Reports To:  Director of Engineering

Job Type:  Full-time or Part-Time

About Us:  Wicked Technologies is a Series-A funded company and leading innovator in the healthcare industry, dedicated to improving the quality of life for individuals with incontinence through our high-quality medical devices. We are committed to excellence in manufacturing and continuous improvement, ensuring our products meet the highest standards of quality and safety.

Job Summary:  We are seeking a skilled and detail-oriented Product Engineer to join our team, focusing on the production of incontinence pad medical devices. The ideal candidate will have a strong background in product design, manufacturing processes, quality control, and project management. This role involves optimizing product design and manufacturing operations, ensuring regulatory compliance, and driving continuous improvement initiatives to enhance product quality and production efficiency.

Key Responsibilities:

• Design, develop, and optimize product and manufacturing processes of incontinence pads, ensuring efficiency, quality, and cost-effectiveness.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Operations, to implement new products and processes.
• Develop and maintain detailed documentation of product design, testing and manufacturing processes, including work instructions, process flow diagrams, and standard operating procedures (SOPs).
• Conduct root cause analysis and implement corrective actions for process-related issues to minimize downtime and improve product quality.
• Evaluate and recommend new equipment, tools, and technologies to enhance manufacturing capabilities.
• Ensure compliance with relevant industry standards and regulatory requirements, including ISO, FDA, and GMP.
• Lead continuous improvement projects using Lean Manufacturing and Six Sigma methodologies to increase efficiency and reduce waste.
• Train and mentor production staff on new processes, equipment, and best practices.
• Monitor production metrics and perform data analysis to identify trends, variances, and opportunities for improvement.
• Participate in audits and inspections to ensure adherence to quality and regulatory standards.

Qualifications:

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• Proven experience in product design and manufacturing engineering, preferably in the medical device industry.
• Strong knowledge of manufacturing processes, quality control, and regulatory requirements for medical devices.
• Proficiency in CAD software and other engineering tools