Technical Lead - Manufacturing Process
United States
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Job Description
Technical Lead - Manufacturing Process
Others, California

Job Summary

As a Technical Lead specializing in Manufacturing Process Planning, you will play a pivotal role in managing technology within projects and offering technical guidance to ensure successful work completion. Your expertise will be instrumental in enhancing team capabilities, ensuring process compliance, and driving the implementation of best practices, ultimately contributing to the organization’s objectives.

Key Responsibilities

  • Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
  • Conduct process characterization using DOE, SPC, and statistical modeling.
  • Perform process capability studies (Cp/Cpk) and implement corrective actions for low‑capability processes.
  • Define and maintain the Process Validation Master Plan (PVMP).
  • Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
  • Support pilot‑to‑production scale‑up for new blood glucose sensor manufacturing lines.
  • Optimize process parameters for yield, throughput, and quality.
  • Lead root‑cause analysis and CAPA activities related to process deviations or excursions.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
  • Support internal, external, and regulatory audits by providing process validation documentation.
  • Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
  • Train technicians and operators on validated processes and control plans.

Skill Requirements

  • Bachelor’s degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
  • 3+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
  • Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
  • Understanding of regulated medical device manufacturing and QMS requirements.

Other Requirements

  • Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
  • Six Sigma Green Belt or Black Belt certification.
  • Experience with automated or semi‑automated process lines.
  • Experience in the semiconductor industry for wafer production.
Maximum Salary (US): 
Minimum Salary (US): 
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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.