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

Job Summary

Responsible for supporting validation, qualification, and lifecycle management of manufacturing equipment for blood glucose monitoring sensors. The role focuses on executing IQ/OQ/PQ activities, defining process parameters, performing risk assessments, and ensuring equipment reliability and compliance with FDA, ISO 13485, and GMP standards while collaborating with cross‑functional teams to enable efficient scale‑up and sustained production performance.

Key Responsibilities

Key Responsibilities

  • Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
  • Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits.
  • Establish preventive maintenance plans, calibration schedules, and critical spare parts lists.
  • Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs).
  • Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies.
  • Perform equipment risk assessments, including pFMEA and hazard analysis.
  • Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts.
  • Train technicians and operators on validated equipment procedures.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
  • Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to high‑volume production.
  • Work with Manufacturing Engineers to improve equipment reliability and throughput.
  • Support internal and external audits by providing equipment validation evidence.

Skill Requirements

1. In-Depth Knowledge Of Manufacturing Process Planning Principles And Methodologies.
2. Advanced Proficiency In Software Development Practices, Including Agile Methodologies And Devops Tools.
3. Strong Understanding Of Quality Assurance Processes And Tools, Such As Jira And Jenkins.
4. Excellent Analytical And Problem-Solving Skills, With The Ability To Assess Technical Risks And Provide Informed Recommendations.
5. Proficient In Stakeholder Management And Communication.

Other Requirements

Required Qualifications

  • Bachelor’s degree in Mechanical, Electrical, Industrial, Biomedical Engineering, or a related field.
  • 3+ years of equipment validation experience within medical device manufacturing.
  • Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements.
  • Familiarity with automated equipment, robotics, PLCs, and machine vision systems.

 

Preferred Qualifications

  • Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production.
  • Experience with high‑speed automation and semi‑automated production lines.
  • Certification in equipment validation or GAMP 5 training.
Maximum Salary (US):  122000
Minimum Salary (US):  80000
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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 226,300 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 December 2025 totaled $14.5 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.