Senior Engineer Textile

Work Flexibility: Hybrid

• 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