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Silicone Materials Development Engineer
2 months ago
We are seeking a Materials Engineer specializing in Silicone to spearhead the development and optimization of silicone materials specifically designed for medical uses, including devices intended for implantation.
Key Responsibilities:- Material Innovation: Direct the creation and enhancement of novel silicone compounds suitable for healthcare applications.
- Process Improvement: Develop and refine silicone manufacturing techniques such as molding, extrusion, calendering, and dip coating to ensure compliance with rigorous quality and precision standards.
- Project Oversight: Manage engineering initiatives from initial concept through to production, guaranteeing adherence to timelines and specifications.
- Quality Control: Work alongside the quality assurance team to formulate comprehensive testing protocols and maintain compliance with industry standards such as FDA and ISO 13485.
- Technical Assistance: Offer expert guidance and problem-solving support to production teams, fostering ongoing enhancements in manufacturing processes.
- Research and Development: Keep abreast of cutting-edge advancements in silicone material science and medical device production to promote innovation within the organization.
- Educational Qualifications: Bachelor’s or Master’s degree in Chemical Engineering, Materials Science, or a related discipline.
- Professional Experience: At least 5 years of experience in silicone material development and processing, ideally within the medical device or healthcare sector.
- Technical Knowledge: Comprehensive understanding of silicone chemistry, processing techniques (including LSR, HCR, and RTV), and applicable regulatory frameworks.
- Analytical Skills: Demonstrated capability to assess complex challenges and devise effective solutions in a manufacturing context.
- Communication Skills: Strong written and verbal communication abilities for effective collaboration with both internal teams and external stakeholders.
- Regulatory Acumen: Knowledge of FDA/CE regulatory standards and experience in developing compliant products.
- Software Skills: Proficiency in CAD software and statistical analysis tools for process design and enhancement.
- Leadership Experience: Proven track record of leading cross-functional teams and managing multiple projects concurrently.
