Project Manager, Regulatory Compliance Specialist, Quality Engineering

HCLTech is looking for a highly talented and self‑motivated Sustaining Engineering Project Manager to join it in advancing the technological world through innovation and creativity.

Sustaining Engineering Project Manager

29993

Full‑time with HCLTech

West Chester, PA

The Project Manager will lead and manage Sustaining Engineering projects for BD’s Acute Care, Home Care, and Dry Doc product lines. This role involves planning, coordinating, and executing engineering changes, compliance activities, and product lifecycle management in alignment with BD’s quality systems. The Project Manager will work closely with cross‑functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure timely delivery of project objectives.

• Develop and manage project plans using MS Project / One Plan.
• Drive project execution from initiation through change notifications (Project Charter, ECR).
• Manage change control and design planning through CCP/DDP/PEGA.
• Coordinate engineering changes for Cost to Win, Line Extension, Quality Improvement, Labeling & Packaging, Supplier Validation, Regulatory Compliance.
• Support design transfer activities and Design History File audits.
• Oversee creation and updates of design control documents (Design Inputs, Traceability Matrix, Specifications, Verification Plans, Protocols & Reports, FMEA).
• Gather requirements and responses from cross‑functional teams.
• Coordinate with BD teams for Design Verification Testing and Process Validation (IQ/OQ/PQ).
• Manage transactions in PLM tools (Master Control, PEGA).
• Prepare project status reports, risk assessments, and obsolescence reports.
• Conduct periodic review with core team members and update the project status to Client portfolio manager.

• Strong Project Management skills with experience in regulated industries.
• Basic R&D and Engineering knowledge (Mechanical/Electrical).
• Proficiency in MS Project (MPP) and MS Office Suite.
• Familiarity with tools like Solid Works, AutoCAD, Minitab (statistical analysis).
• Excellent communication and stakeholder management skills.
• Cross‑functional coordination and collaboration skills.

• Bachelor’s degree in mechanical engineering.
• 10+ years of experience in Project Management, preferably in Medical Devices or regulated industry.
• Knowledge of ISO 13485 / QSR 21 CFR Part 820 is an advantage.

• MS Project
• Master Control
• PEGA
• One Plan
• Solid Works
• AutoCAD
• Minitab

• 4 days Working from Office is mandatory currently and it should be inline with client policy.

Pay Range Minimum: $40.0 per hour

Pay Range Maximum: $45.00 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.

Compensation and Benefits

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…