Senior Developer

HCL Technologies Limited; El Paso (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) retirement plan

Paid Time Off

Holidays

Job summary

HCLTech seeks a Packaging Engineer to design, develop, validate, and improve packaging systems for medical devices. The role collaborates with Manufacturing, Quality, R&D, Regulatory Affairs, Supply Chain, and suppliers to ensure compliant packaging solutions.

Responsibilities include packaging design, validation, regulatory compliance activities per FDA/ISO standards, CAPA, and cost optimization initiatives across the product lifecycle.

Qualifications

• Bachelor's degree in Packaging Engineering or related technical field.

Responsibilities

• Design, develop, and implement primary, secondary, and tertiary packaging systems for medical devices.

Skills

Problem solving

Project management

Verbal communication

Written communication

Cross-functional collaboration

Continuous improvement

Analytical thinking

Education

Bachelor's degree in Packaging Engineering

3+ years of engineering experience in packaging or regulated environment

Tools

CAD

Minitab

SAP

Oracle

Microsoft Office Suite

Job description

ThePackaging Engineeris responsible for the design, development, validation, implementation, and continuous improvement of packaging systems for medical devices manufactured at the site. This role ensures packaging solutions meet product protection, regulatory, quality, operational, and customer requirements while supporting FDA remediation activities, process optimization, product launches, and cost reduction initiatives. The Packaging Engineer collaborates closely with Manufacturing, Quality, R&D, Regulatory Affairs, Supply Chain, and external suppliers to deliver compliant and efficient packaging solutions.

Key Responsibilities

Packaging Design & Development

• Design, develop, and implement primary, secondary, and tertiary packaging systems for medical device products.
• Evaluate packaging materials, components, and configurations to ensure product protection and performance throughout the product lifecycle.
• Support new product introductions (NPI), product transfers, and packaging changes.
• Develop packaging specifications, drawings, bill of materials (BOMs), and technical documentation.

Validation & Regulatory Compliance

• Develop and execute packaging validation protocols, including:
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Support packaging process validation activities in compliance with:
  • FDA Quality System Regulations (21 CFR Part 820)
  • ISO 13485
  • ISO 11607
  • Good Manufacturing Practices (GMP)
• Participate in risk assessments, FMEAs, and design reviews.
• Ensure compliance with BD quality standards and documentation requirements.

Manufacturing Support

• Provide engineering support for packaging operations and manufacturing processes.
• Investigate packaging-related quality issues and implement corrective and preventive actions (CAPA).
• Lead root cause investigations using structured problem-solving methodologies.
• Support nonconformance investigations and continuous improvement initiatives.
• Partner with operations teams to improve packaging efficiency, quality, and productivity.
• Identify and execute cost reduction and process improvement opportunities.
• Utilize Lean Manufacturing and Six Sigma tools to improve packaging performance.
• Drive initiatives related to waste reduction, material optimization, and operational excellence.
• Support digitalization and automation opportunities within packaging processes.

Cross-Functional Collaboration

• Collaborate with R&D, Product Development, Quality Assurance, Regulatory Affairs, Supply Chain, Procurement, and Manufacturing teams.
• Interface with packaging material suppliers and contract manufacturers.
• Support internal and external audits, including FDA inspections and customer audits.
• Provide technical expertise on packaging-related projects and change controls.

Education & Experience

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Biomedical Engineering, or related technical field.
• 3+ years of engineering experience in packaging, manufacturing, medical device, pharmaceutical, or highly regulated industries.
• Experience with packaging validation and testing methodologies.
• Experience supporting manufacturing operations and quality systems.

Technical Skills

• Packaging materials and technologies
• Packaging equipment and automation systems
• FDA regulations and GMP requirements
• Statistical analysis and validation methodologies
• Risk management and FMEA processes
• Root cause analysis and CAPA systems
• Microsoft Office Suite
• SAP, Oracle, or similar ERP systems
• Statistical software (Minitab preferred)
• CAD software preferred
• Strong analytical and problem-solving skills.
• Excellent project management abilities.
• Effective verbal and written communication skills.
• Ability to influence cross-functional teams.
• Strong organizational and documentation skills.
• Results-oriented with a continuous improvement mindset.
• Ability to work in manufacturing and cleanroom environment

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 2026totaled $14.8billion.

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.