Senior Engineer Textile

What you will do:

• Expertise intextile 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 intestingper ISO 10993 standards including cytotoxicity irritation sterilization validation mechanical performance (tensile tear abrasion) and microbial barrier testing.

• Strong capability inprocess developmentandfinalization 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.

What you will need:

Required Qualification:

• Bachelors degree inTextile Engineeringor closely related field (e.g. Materials Science with textile specialization); Masters 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 approachesProcess Qualification(e.g. IQ/OQ/PQ protocols)Leanmethodologies for waste reduction andSix Sigma(Green Belt certification preferred) for process optimization and defect prevention.

Preferred skills:

• Experience in an FDA regulated or regulated industry

• Ability to read and interpret complex engineering drawings and can understand geometrical dimension andtolerances

• 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