Senior Developer - Manufacturing Process

HCL Technologies Limited; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Sapsf is seeking a Senior Developer - Manufacturing Process to lead design and development of catheter-based medical devices. The role emphasizes building prototypes, understanding customer requirements, and working across global teams.

The ideal candidate has 5+ years in R&D or manufacturing engineering in the medical device sector, with experience in regulated environments (FDA/ISO) and Lean process improvements.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Manufacturing process planning

SDLC methodologies

Manufacturing software

CMMI standards

Communication skills

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

Cmmi Certification

Job description

Career Opportunities: Senior Developer - Manufacturing Process (114196)

Requisition ID114196-Posted10/01/2026

• 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.