Medical-Device Manufacturing Process Engineer

Occlutech; Bakırköy; On-site; TRY 240,000 - 420,000; Full time

Job summary

Occlutech is seeking a Manufacturing Process Engineer to optimize and validate production processes for cardiac devices. The role focuses on interface across Production, R&D and Maintenance to ensure robust, efficient manufacturing throughout the product lifecycle.

The candidate will manage equipment acquisition, supplier coordination, machine start-up, validation support and documentation, while driving quality improvements and CAPA activities on the shop floor.

Qualifications

• Experience in the medical device industry is preferred.
• Knowledge and experience in development and implementation of manufacturing systems and processes.
• Experience in project management.
• Experience in risk management (especially Process FMEA).
• Knowledge of Medical Device Manufacturing standards, audits and inspection techniques.
• Knowledge of CAD tools preferred.
• Experience with QMS according to ISO 13485.

Responsibilities

• Interface between Production, R&D, and Maintenance to ensure robust production processes throughout the product lifecycle.
• Specify equipment and coordinate with suppliers; support validation and documentation.
• Lead manufacturing-related activities for changes and continuous improvements; transfer designs to production.
• Support CAPAs, ECRs and other QMS-related processes in Manufacturing.

Skills

Process engineering

Manufacturing systems

Project management

Risk management (P-FMEA)

QMS ISO 13485

Communication

English (B2)

Tools

CAD tools

Job description

Occlutech is seeking a Manufacturing Process Engineer to optimize and validate production processes for cardiac devices. The role focuses on interface across Production, R&D and Maintenance to ensure robust, efficient manufacturing throughout the product lifecycle.

The candidate will manage equipment acquisition, supplier coordination, machine start-up, validation support and documentation, while driving quality improvements and CAPA activities on the shop floor.