Senior Medical Device Process Engineer

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.