Teams at Cretex Medical

Develop and validate manufacturing processes for new medical device products, from design for manufacturability through production launch. Responsibilities include process characterization, IQ/OQ/PQ validation, DOE and statistical analysis, root-cause troubleshooting, fixture and equipment design, risk assessment, documentation, customer support, and cross-functional collaboration with Quality, Development, and Manufacturing. The role also mentors engineers and technicians, supports lean and automation initiatives, and works in ISO 13485/GMP and cleanroom environments.

Provides quality engineering support for medical device manufacturing by developing inspection and control plans, facilitating PFMEAs, resolving discrepancies, conducting audits, supporting process and equipment validation, analyzing data, and driving corrective actions and continuous improvement. The role partners with production, engineering, and customers while maintaining compliance with quality systems, ISO standards, and medical device requirements.

Leads the development, validation, optimization, and implementation of advanced manufacturing processes for medical device components and assemblies. Responsibilities include defining process parameters, troubleshooting production issues, analyzing data, creating technical documentation, supporting quality systems, managing project timelines, collaborating with customers and cross-functional teams, and mentoring junior engineers. The role requires manufacturing process design, validation, lean methods, statistical analysis, and medical device quality-system knowledge.