Description

Design medical device products, prototypes, and manufacturing equipment. Own the transition from prototype to manufactured components while ensuring regulatory compliance and data integrity.

Responsibilities

• Design products, fixtures, and equipment for medical device applications using SOLIDWORKS.
• Design and execute experiments to derive data-based conclusions on process and product performance.
• Operate processing equipment, including mechanical testing tools and 3D printers (VP, FFF).
• Procure and implement new testing and manufacturing equipment using IQ/OQ/PQ validation techniques.
• Maintain laboratory notebooks and write technical reports following GDP practices.

Required Skills

• 5+ years of experience in R&D or design roles.
• Proficiency in SOLIDWORKS for 3D CAD design.
• Hands-on experience with mechanical testing equipment, fixture design, and test method execution.
• Experience operating, tuning, and maintaining 3D printers (VP, FFF).
• Knowledge of performing test methods in accordance with USP, FDA, ISO, or ASTM standards.
• Familiarity with material characterization techniques (UV VIS, NMR, FTIR, GC, rheology, GPC, HPLC).
• Experience with polymer processing (extrusion, solvent casting, dip coating, mixing) and polymeric synthesis.
• Understanding of statistical methods and statistical analysis software.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).

Preferred Skills

• Experience with bioabsorbable or bioresorbable materials.
• Experience working in ISO 9001, ISO 13485, or GMP facilities.
• Experience using Minitab for statistical analysis.

Key Skills

Education

Any Gradute