About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry.  Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.  Learn more at www.cretexmedical.com. 

Manufacturing Engineer III Position Summary 

The Manufacturing Engineer III leads the development, validation, and optimization of complex manufacturing processes for medical devices, with a focus on plastic injection molding and assembly. This role drives design-for-manufacturability, resolves high-impact technical issues, mentors other engineers, and ensures compliance with ISO 13485, GMP, and Quality System requirements.

• Lead development and implementation of new and improved manufacturing processes to support current and next-generation medical device programs
• Apply advanced engineering principles to solve complex, high-risk manufacturing and quality problems, including novel or non-standard solutions
• Partner with Quality, Manufacturing, and Supply Chain to transfer new products and processes into production
• Own and approve manufacturing documentation, including routers, bills of material, and procedures
• Monitor and optimize equipment, tooling, and process performance to improve yield, capability, and product quality
• Design, specify, and implement fixtures, gauges, and manufacturing aids
• Lead resolution of nonconformances and actively participate in Material Review Board (MRB) activities
• Analyze and improve manufacturing processes using Lean, SPC, DOE, and FMEA methodologies
• Support cost estimation and cost-reduction initiatives
• Mentor and technically guide Manufacturing Engineers I and II
• Ensure full compliance with ISO 13485, GMP, QSR, and internal Quality System requirement

• Bachelor’s degree in Mechanical, Industrial, or related Engineering discipline
• 5+ years manufacturing engineering experience, preferably in medical devices
• Demonstrated experience in process design, validation (IQ/OQ/PQ), and production support
• Strong working knowledge of ISO 13485, GMP, and FDA QSR
• Experience with plastic injection molding, assembly processes, and manufacturing automation
• Proficiency in DOE, SPC, FMEA, and statistical analysis software
• Experience designing fixtures, gauges, and manufacturing equipment
• Familiarity with Lean manufacturing principles
• Proficiency in 3D CAD software (e.g., SolidWorks, Creo, NX)
• Strong project management, communication, and cross-functional leadership skills
• High level of ownership, integrity, attention to detail, and ability to manage ambiguity and competing priorities