Project Manager

HCLTech; California (MO); On-site; USD 55,104 - 61,992; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

10 Days Paid Time Off

Performance-based Bonuses

Job summary

HCLTech is seeking a Sustaining Engineering Project Manager to lead engineering projects for BD’s AcuteCare and HomeCare product lines. The role integrates project management with compliance analysis and product lifecycle oversight.

The ideal candidate holds a Bachelor's in Mechanical Engineering and possesses over a decade of experience in regulated industries. This position requires proficiency in MS Project and collaboration across multiple teams.

Qualifications

• 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.
• Experience in regulated industries.

Responsibilities

• Lead and manage Sustaining Engineering projects for BD’s product lines.
• Coordinate engineering changes for various product enhancements.
• Manage project plans and documentation in alignment with quality systems.

Skills

Project Management

R&D Knowledge

MS Project Proficiency

SolidWorks Familiarity

Excellent Communication

Cross-functional Coordination

Education

Bachelor's degree in Mechanical Engineering

Tools

MS Project

MasterControl

PEGA

SolidWorks

AutoCAD

Minitab

Job description

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.

Job Title:

Sustaining Engineering Project Manager

Job ID:

29993

Position Type:

Full‑time with HCLTech

Location:

West Chester, PA

Role/Responsibilities:

Job Summary

The Project Manager will lead and manage Sustaining Engineering projects for BD’s AcuteCare, HomeCare, and DryDoc 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.

Key Responsibilities

• Develop and manage project plans using MS Project / OnePlan.
• 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 (MasterControl, 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.

Required Skills

• 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 SolidWorks, AutoCAD, Minitab (statistical analysis).
• Excellent communication and stakeholder management skills.
• Cross‑functional coordination and collaboration skills.

Qualifications

• 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.

Tools & Systems

• MS Project
• MasterControl
• PEGA
• OnePlan
• SolidWorks
• AutoCAD
• Minitab

Other Requirements – Working from Office

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

Pay and Benefits

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 [e-mail] 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 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.