Lead Implant Process Development Engineer, TMVR

4C Medical Tech; Don Mariano Marcos; On-site; PHP 600,000 - 1,200,000; Full time

Job summary

4C Medical Tech in the Philippines is seeking a Principal Process Development Engineer to lead the development, optimization, and validation of manufacturing processes for our transcatheter mitral valve replacement system. You will guide process engineering, fixture development, and protocol execution in a fast-paced production environment.

Collaborate with Operations, Quality, and Engineering to ensure capable, repeatable processes that meet FDA/ISO requirements, improve yield, and drive

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 3 years in medical device engineering.
• Experience with manufacturing process development and validation.
• Familiarity with inspection equipment (laser micrometers, calipers, drop gauges).
• Strong communication and problem-solving skills.
• Able to work in cleanroom and meet safety/quality standards.

Responsibilities

• Lead process development, optimization, and validation for TMVR implant manufacturing.
• Support final implant acceptance, troubleshoot issues, improve yield and quality.
• Develop master validation plans and execute IQ/OQ/PQ tests.
• Create and maintain process docs and work instructions.
• Evaluate new technologies and equipment for process improvements.
• Collaborate with Operations, Quality, and Engineering to resolve challenges.
• Ensure compliance with quality systems, cleanroom requirements, and regulatory requirements.

Skills

Process development

Validation planning

Manufacturing support

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Laser micrometers

Calipers

Drop gauges

Job description

4C Medical Tech in the Philippines is seeking a Principal Process Development Engineer to lead the development, optimization, and validation of manufacturing processes for our transcatheter mitral valve replacement system. You will guide process engineering, fixture development, and protocol execution in a fast-paced production environment.

Collaborate with Operations, Quality, and Engineering to ensure capable, repeatable processes that meet FDA/ISO requirements, improve yield, and drive