Job Description

Key Responsibilities:

• Material Development: Lead the formulation and development of new silicone materials tailored for medical applications, including implantable devices.
• Process Optimization: Design, implement, and optimize silicone fabrication processes, including molding, extrusion, calendering, and dip coating, to meet strict tolerance and quality standards.
• Project Management: Oversee engineering projects from concept through production, ensuring timely delivery and adherence to specifications.
• Quality Assurance: Collaborate with the quality team to establish robust testing protocols and ensure compliance with FDA, ISO 13485, and other relevant standards.
• Technical Support: Provide technical guidance and troubleshooting for production teams, ensuring continuous improvement of manufacturing processes.
• Innovation: Stay updated on the latest advancements in silicone material science and medical device manufacturing to drive innovation within the company.

Qualifications:

• Educational Background: Bachelors or Masters degree in Chemical Engineering, Materials Science, or a related field.
• Experience: Minimum of 5 years of experience in silicone material development and processing, preferably in a medical device or healthcare-related industry.
• Technical Expertise: Strong knowledge of silicone chemistry, processing methods (such as LSR, HCR, and RTV), and relevant regulatory standards.
• Problem-Solving Skills: Proven ability to analyze complex problems and implement effective solutions in a manufacturing environment.
• Communication: Excellent written and verbal communication skills for effective collaboration with internal teams and external clients.

Preferred Qualifications:

• Regulatory Knowledge: Familiarity with FDA/CE regulatory requirements and experience in developing products that meet these standards.
• Software Proficiency: Experience with CAD software and statistical analysis tools for process design and optimization.
• Project Leadership: Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously.

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