Jobs 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.

Supports employees and leaders with day-to-day HR needs in an in-person manufacturing environment. Administers leave of absence and workers’ compensation processes, maintains records and timekeeping accuracy, facilitates onboarding and employee check-ins, supports offboarding and unemployment claims, provides policy and employee-relations guidance, and contributes to reporting, workplace committees, and HR process improvements.

Leads manufacturing process development, design for manufacturability, continuous improvement, equipment and fixture implementation, process validation, and production support for medical device components and assemblies. Responsibilities include maintaining routers, bills of materials, procedures, and quality documentation; resolving equipment issues and nonconformances; supporting material review; analyzing process efficiency; estimating costs; mentoring engineers; and ensuring compliance with ISO 13485, GMP, and medical device requirements.

Manages customer medical device programs from prototyping through production, overseeing scope, schedules, budgets, quality, risks, quotations, customer communication, and production transfer. Coordinates cross-functional engineering, manufacturing, quality, operations, supply chain, and scheduling teams to meet delivery and margin goals. Facilitates audits, root-cause analysis, S&OP planning, and risk mitigation while ensuring compliance with customer, industry, ISO 13485, and FDA requirements.

Supports quality engineering projects from scope definition through implementation. Provides technical support for manufacturability, process improvements, and design improvements; follows quality systems, ISO, medical device requirements, work instructions, and standard work. Collaborates with sales, customer service, engineering, quality, and finance teams while assisting with customer needs and manufacturing processes.

Support manufacturing and warehousing operations by implementing barcode system improvements, mapping workflows, configuring and testing hardware and software, and assisting with deployment. Create work instructions, troubleshooting guides, training materials, diagrams, and flowcharts while maintaining document version control. Collaborate with engineering, IT, and operations teams, interpret technical information, and ensure compliance with quality systems, ISO standards, and medical device regulations.

Manufacturing Engineer Interns provide technical support for manufacturing, quality, and operational excellence projects. They assist with projects from scope definition through implementation, support part manufacturability, provide internal customer guidance, and help implement process and design improvements. The role requires enrollment in a four-year Manufacturing, Mechanical, or Industrial Engineering program, blueprint-reading ability, measuring-device proficiency, and strong communication and teamwork skills.

Supports quality engineering projects from scope definition through implementation. Provides technical support for internal customers and part manufacturability, assists with process and design improvements, and follows company quality systems, ISO standards, and medical device requirements. Collaborates with sales, customer service, engineering, quality, and finance teams while reading blueprints, using measuring devices, and applying problem-solving skills in an onsite manufacturing environment.

Supports manufacturing engineering projects from scope definition through implementation. Provides technical assistance on part manufacturability, process and design improvements, blueprint interpretation, measurement, and compliance with quality systems and medical device requirements. Collaborates with engineering, quality, sales, customer service, and finance teams while following work instructions and standard practices.

Supports automation projects from scope definition through implementation, providing technical support and helping enhance electrical and controls systems. Assists with project design, implementation, scheduling, safety, cost, and quality objectives while following ISO and medical device requirements. Collaborates with engineering, quality, finance, sales, and customer service teams. Uses SolidWorks and Microsoft Office, prioritizes multiple tasks, and contributes to a fast-paced manufacturing environment.