Control Design Engineer

HCLTech is looking for a highly talented and self‑motivated Design ControlLead to join it in advancing the technological world through innovation and creativity. Job Title: Design ControlLead Job ID: 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 View email address on click.appcast.io for investigation. #J-18808-Ljbffr HCLTech