Process Development Associate Engineer

About the role

Biomerics is seeking a Process Development Associate Engineer to program, validate, train personnel, and document CNC processes for critical medical device components. The role ensures accuracy, stability, and regulatory compliance in production.

Key responsibilities

• Create and optimize CNC programs, defining cutting parameters, tooling, and machining sequences.
• Develop Quality Plans, Manufacturing Process Instructions, and maintain Bill of Materials.
• Coordinate Test Method Validations and First Article Inspections.
• Identify and control Critical to Quality product characteristics.
• Prepare documentation for process and product validation and ensure compliance with ISO 13485 and FDA regulations.

Required profile

• CNC Specialist Technician or university degree in Mechanical/Electromechanical Engineering or related field.
• Bilingual English‑Spanish proficiency (B2).
• Minimum 2 years CNC programming and high‑precision metalworking experience in the medical device industry.

Required skills

• CNC programming experience with Fanuc, Citizen, Star, Tsugami, Willemin and ESPRIT.
• Knowledge of high‑precision metalworking processes.
• Experience with IQ/OQ/PQ validations, FMEA and SPC.
• Familiarity with ISO 13485 standards and Lean/Six Sigma methodologies.