Senior Developer - Manufacturing Process

Job Summary

Manufacturing and R&D:

• Bachelor’s degree in engineering (Mechanical or related); master’s preferred
• 5+ years of experience in R&D or manufacturing engineering (medical device preferred)
• Design and develop catheter-based medical devices, including building prototypes
• Understand customer and product design requirements
• Ability to work independently and in cross-functional, global teams
• Develop test methods & Inspections Methods
• Experience with regulated environments (FDA, ISO)
• Knowledge of manufacturing processes and product development lifecycle
• Lead or support process improvements, validations (FMEA), and new product introduction
• Improve quality, efficiency, and throughput using Lean principles
• Ensure design for manufacturability and support tooling/equipment development

Key Responsibilities

Manufacturing and R&D:

• Bachelor’s degree in engineering (Mechanical or related); master’s preferred
• 5+ years of experience in R&D or manufacturing engineering (medical device preferred)
• Design and develop catheter-based medical devices, including building prototypes
• Understand customer and product design requirements
• Ability to work independently and in cross-functional, global teams
• Develop test methods & Inspections Methods
• Experience with regulated environments (FDA, ISO)
• Knowledge of manufacturing processes and product development lifecycle
• Lead or support process improvements, validations (FMEA), and new product introduction
• Improve quality, efficiency, and throughput using Lean principles
• Ensure design for manufacturability and support tooling/equipment development

Skill Requirements

1. Strong Understanding Of Manufacturing Process Planning Principles And Practices.
2. Familiarity With Software Development Life Cycle (Sdlc) Methodologies.
3. Proficient In Relevant Programming Languages And Technologies Used In Manufacturing Applications.
4. Basic Knowledge Of Cmmi Documentation Standards And Practices.
5. Good Communication Skills For Effective Collaboration With Clients And Team Members.

Other Requirements

1. Optional But Valuable: Cmmi Certification.
2. Optional But Valuable: Relevant Certifications In Software Development Or Manufacturing Processes.