Job details
Expertise in textile materials (e.g., non-wovens, knits, braids, woven fabrics) suitable for medical use, focusing on properties like absorbency, strength, hypo allergenicity, and barrier performance.
Proficiency in testing per ISO 10993 standards, including cytotoxicity, irritation, sterilization validation, mechanical performance (tensile, tear, abrasion), and microbial barrier testing.
Strong capability in process development and finalization, from lab-scale prototyping to scalable manufacturing under cleanroom conditions.
Process development skills: Design of Experiments (DoE) for parameter optimization, scale-up strategies from pilot to production, equipment selection and validation (e.g., weaving looms, knitting machines, coating lines), and statistical process control (SPC) for capability analysis (Cp/Cpk).
Advanced knowledge of textile processing techniques: yarn spinning, fabric construction methods, finishing treatments (e.g., plasma, antimicrobial coatings), and integration with medical assembly processes.
Supplier management: Select, audit, and qualify suppliers for medical-grade textiles, ensuring traceability, risk management, and deviation resolution per ISO 13485.
PPAP documentation & closure: Prepare and submit Production Part Approval Process packages adapted for medical devices (similar to AIAG PPAP), including process flows, FMEAs, control plans, and MSA for full approval.
- Bachelor's degree in Textile Engineering or closely related field (e.g., Materials Science with textile specialization); Master's preferred for senior roles.
- 3-5 years of hands-on experience in textile engineering within medtech, automotive textiles, or similar regulated industries.
- Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
- Knowledge of GMP, FDA 21 CFR Part 820, EU MDR, risk-based validation approaches, Process Qualification (e.g., IQ/OQ/PQ protocols), Lean methodologies for waste reduction, and Six Sigma (Green Belt certification preferred) for process optimization and defect prevention.
Experience in R&D, new product development, or process design
Experience in an FDA regulated or regulated industry
Ability to read and interpret complex engineering drawings and can understand geometrical dimension and tolerances
Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design
CAD experience
