Control Design Engineer Job Raritan area,New Jersey USA,Quality Assurance

HCLTech is looking for a highly talented and self‑motivated Design Control Lead to join it in advancing the technological world through innovation and creativity.

Job Title: Design Control Lead

Job : 97397

Position Type: Full‑time with HCLTech

Location: RARITAN, NEW JERSEY

Job Description

Design Control, Risk management in Lead role. (DQE preferred). Minimum Level 4+ Yrs of Experience in Design Control required.

Key Responsibilities

Design Controls & Requirements Management

Review customer, business, and regulatory requirements for clarity, completeness, consistency, and testability
Ensure design inputs are defined, approved, traceable, and controlled
Establish and maintain end‑to‑end traceability between requirements, design outputs, risks, and tests
Participate in requirements reviews and VOC analysis

Lead or support design risk management activities, including:

DFMEA / FMEA
Hazard analysis
Use‑related risk assessments (where applicable)
Ensure risks are properly mitigated and traced to design controls and verification activities
Support risk‑benefit analysis and residual risk evaluation
Ensure design outputs (drawings, specifications, software artifacts) correctly implement design inputs

Verify documentation completeness, accuracy, and version control

Identify and drive closure of quality gaps and non‑conformances
Review and approve design verification plans, protocols, and acceptance criteria
Track verification coverage and ensure timely closure of gaps
Review verification reports and objective evidence

Design Validation

Support design validation planning and execution
Ensure validation represents intended use and user needs
Review validation results, deviations, and corrective actions
Confirm unresolved issues are documented and risk‑assessed

Design Change & Configuration Management

Review and approve design changes from a quality and compliance perspective
Perform or support change impact analysis
Ensure re‑verification or re‑validation is triggered when required
Maintain configuration control and documentation integrity

Regulatory Compliance & Audit Support

Ensure design activities comply with applicable quality standards and regulations
Support internal audits, external audits, and regulatory inspections
Maintain and support Design History File (DHF) or equivalent technical documentation
Participate in mock audits and compliance gap assessments

Cross‑Functional Collaboration

Act as the quality interface between:
Regulatory Affairs
Manufacturing
Testing and Program teams
Provide quality guidance and training to project teams

Required Qualifications

Education: Bachelor’s degree in Engineering, Quality, or a related technical field

Experience: Design Control, Risk management in Lead role. (DQE preferred). Minimum Level 4+ Yrs of Experience in Design Control required.

Experience working in cross‑functional product development teams

Exposure to regulated or high‑reliability product environments preferred

Technical & Quality Skills

Design Controls and Design Assurance
Risk Management (FMEA, Hazard Analysis)
Requirements and traceability management
Change control and configuration management

Tools & Systems

Document management systems
Test and defect management tools

Soft Skills

Strong attention to detail
Analytical and structured thinking
Effective communication and stakeholder management
Ability to influence without authority
Audit and compliance mindset

Pay and Benefits

Pay Range Minimum: $50.0 per hour

Pay Range Maximum: $52.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to for investigation.

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