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 healthcarerelated industry.
Technical Expertise: Strong knowledge of silicone chemistry processing methods (such as LSR HCR and RTV) and relevant regulatory standards.
ProblemSolving 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 crossfunctional teams and manage multiple projects simultaneously.
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