Senior Developer - Manufacturing Process (US)
Role Overview
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
Full Job Posting
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
- Strong Understanding Of Manufacturing Process Planning Principles And Practices.
- Familiarity With Software Development Life Cycle (Sdlc) Methodologies.
- Proficient In Relevant Programming Languages And Technologies Used In Manufacturing Applications.
- Basic Knowledge Of Cmmi Documentation Standards And Practices.
- Good Communication Skills For Effective Collaboration With Clients And Team Members.
- Optional But Valuable: Cmmi Certification.
- Optional But Valuable: Relevant Certifications In Software Development Or Manufacturing Processes.
Skill Requirements
Strong Understanding Of Manufacturing Process Planning Principles And Practices. Familiarity With Software Development Life Cycle (Sdlc) Methodologies. Proficient In Relevant Programming Languages And Technologies Used In Manufacturing Applications. Basic Knowledge Of Cmmi Documentation Standards And Practices. Good Communication Skills For Effective Collaboration With Clients And Team Members.
Other Requirements
Optional But Valuable: Cmmi Certification. Optional But Valuable: Relevant Certifications In Software Development Or Manufacturing Processes.
Qualifications
- Experience with regulated environments (FDA, ISO)
- Familiarity With Software Development Life Cycle (Sdlc) Methodologies.
Preferred Qualifications
- Bachelor’s degree in engineering (Mechanical or related); master’s preferred
About HCL Technologies
HCL Technologies is a global IT services and consulting company offering digital, engineering, cloud, and AI solutions. Headquartered in Noida, India, it serves clients across industries in over 60 countries.
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