Design Quality Engineer

HCL Technologies Limited; Raritan (NJ); On-site; USD 69,000 - 77,000; Full time

Benefits offered by this job

Medical insurance

Dental/Vision coverage

401(k) retirement plan

Paid time off ( PTO )

Job summary

HCLTech is seeking a Design Quality Engineer to advance medical device development with emphasis on design controls, risk management, and regulatory compliance. This role requires hands-on experience in design and development, and leads documentation and regulatory activities in a fast-paced environment.

The candidate will participate in CAPA investigations, review DHF deliverables, and ensure adherence to ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971.

Qualifications

• Hands-on experience in medical device design and development.
• Experience with FDA-regulated Design Controls, Change Controls, and NPD.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.

Responsibilities

• Participate in CAPA and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive improvement.
• Serve as a Design Quality SME during audits and inspections.
• Review Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product and supplier changes for quality/regulatory impact.

Skills

Design Controls

Quality Assurance

Education

BE/M.Tech in Mechanical Engineering

Tools

IQ/OQ/PQ

TMV

MSA

Job description

HCLTech is looking for a highly talented and self- motivated Design Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Design Quality Engineer

Job ID: 166438

Position Type: Full-time with HCLTech

Job Summary

DQE with Component Qualification experience

BE/M.Tech in Mechanical Engineering or Equivalent degree

5-9 Years

Job Description

• Hands-on experience in medical device design and development.
• Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
• Hands-on experience in Component Qualification and Process Validation activities.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product, process, and supplier changes for quality and regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.

Key Words search

Medical Device - Design Control

ISO 13485, ISO 14971 and FDA 21 CFR Part 820

Design History Files (DHF)

IQ, OQ, PQ, TMV, MSA

Pay and Benefits

Pay Range Minimum: $50.0 per hour

Pay Range Maximum: $56.00 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 [e-mail] for investigation.

A candidate’s pay within the range will depend on their work location, 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.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.