Manufacturing Engineer - Medical Devices: Process & Validation

3PE; Fontana (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

3PE is looking for a professional to manage manufacturing processes and drive product development. This role involves collaborating with R&D and Engineering, ensuring compliance with FDA regulations, and developing documentation for manufacturing.

Qualified candidates should have knowledge of medical device materials and manufacturing processes. The position promises an engaging work environment that focuses on innovation and quality standards in medical products.

Qualifications

• Knowledge of materials related to medical devices.
• Knowledge of medical manufacturing processes.
• Experience in process validation and risk analysis.

Responsibilities

• Manage product development improvements and training in a pilot or production setting.
• Lead the development of manufacturing processes for new products.
• Comply with FDA and international regulatory standards.
• Develop manufacturing documentation and qualifications for tooling/equipment.
• Work with outside suppliers and departments.

Skills

Knowledge in materials associated with medical devices

Knowledge in processes associated with medical manufacturing

Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis

Proficiency with programming languages (g-code, CO++, VB)

Job description

3PE is looking for a professional to manage manufacturing processes and drive product development. This role involves collaborating with R&D and Engineering, ensuring compliance with FDA regulations, and developing documentation for manufacturing.

Qualified candidates should have knowledge of medical device materials and manufacturing processes. The position promises an engaging work environment that focuses on innovation and quality standards in medical products.