NPS Validation Engineer

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

Job Title: [NPS Validation Engineer]

Job ID: (86383)

Position Type: Full-time

Location: Plano, Texas (Onsite)

Skills / Experience

·3 to 4 years of experience in non-product software validation (specifically in Manufacturing) in Medical devices industry

·Knowledgeable of FDA 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines and FDA 21 CFR Part 11.

·Knowledge of SDLC, validation methodologies, and strongly committed to QMS processes.

·Develop, review, and approve non-product software validation deliverables, including User Requirements Specifications (USR); Risk Assessment, Validation Plans, Test Protocols (IQ); Traceability Matrices, Validation Report.

·Cross‑Functional Collaboration: partner with Quality Assurance, Operations, and cross-functional teams to define software requirements, assess risks, and ensure proper Software/System Test Lifecycle Management (SLC/STLC)

·Ensure risk-based approaches are consistently applied throughout software validation.

·Ensure software and digital tools meet compliance requirements for electronic records, electronic signatures, data integrity, and cybersecurity.

·Support the deployment, upgrade, and change control of quality management systems (QMS), manufacturing systems (MES), lab systems and other software tools. Maintain validated state through periodic reviews, revalidation, and documentation updates

·Experience in Statistical data analytics (Minitab)

·Good communication skills & Experience working with cross functional teams

·Bachelor's in computer science; Software Engineering; an equivalent combination of education and work experience.

Pay and Benefits

Pay Range Minimum: $83,200 per Year

Pay Range Maximum: $1,04,000 per Year

HCLTech 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 secure@hcltech.com for investigation.

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

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.