Manufacturing Process Developer
United States
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Job Description
Manufacturing Process Developer
Others, California

Job Summary

  • 5+ years of Medical device Manufacturing experience
  • Support in Manufacturing process remediation and readiness activities for new product launch.
  • Support Design Transfer deliverables, including tracking and scheduling.
  • Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
  • Risk Management updates – PFMEA.
  • Part creation in Windchill. BOM and configuration management.
  • Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Preferred

  • Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
  • Previous medical device experience

Key Responsibilities

  • 5+ years of Medical device Manufacturing experience
  • Support in Manufacturing process remediation and readiness activities for new product launch.
  • Support Design Transfer deliverables, including tracking and scheduling.
  • Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
  • Risk Management updates – PFMEA.
  • Part creation in Windchill. BOM and configuration management.
  • Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Preferred

  • Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
  • Previous medical device experience

Skill Requirements

  • 5+ years of Medical device Manufacturing experience
  • Support in Manufacturing process remediation and readiness activities for new product launch.
  • Support Design Transfer deliverables, including tracking and scheduling.
  • Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
  • Risk Management updates – PFMEA.
  • Part creation in Windchill. BOM and configuration management.
  • Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Preferred

  • Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
  • Previous medical device experience

Other Requirements

  • 5+ years of Medical device Manufacturing experience
  • Support in Manufacturing process remediation and readiness activities for new product launch.
  • Support Design Transfer deliverables, including tracking and scheduling.
  • Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
  • Risk Management updates – PFMEA.
  • Part creation in Windchill. BOM and configuration management.
  • Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Preferred

  • Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
  • Previous medical device experience
Maximum Salary (US):  86000
Minimum Salary (US):  45000
Apply now
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion. 

 

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.