Lcm Engineer

Tata Consultancy Services; West Chester (Chester County); On-site; USD 90,000 - 95,000; Full time

Benefits offered by this job

Discretionary Annual Incentive

Medical Coverage

Parental Leaves

Auto & Home Insurance

Training Reimbursement

Vacation & Holidays

Job summary

Tata Consultancy Services Limited in West Chester, PA, is seeking an Engineer to lead technical Life Cycle Management projects for finished goods, coordinating with external manufacturing partners to ensure timely, within-scope delivery in line with business objectives.

The role requires strong communication across Quality, R&D, Regulatory, and Operations, with hands-on experience in medical device quality systems and PLM tools. This is a full-time on-site position in technology functions.

Qualifications

• Degree in manufacturing engineering in orthopedics (metal implants) or equivalent.
• 5+ years of hands-on medical device quality systems experience.
• Knowledge of FDA, MDD and MDR GMP requirements.
• Experience leading cross-functional teams and effective communication.

Responsibilities

• Lead and execute technical Life Cycle Management (LCM) projects with external partners.
• Provide technical oversight and project leadership for external manufacturers.
• Use PLM systems (Windchill) to manage documentation and change controls.
• Collaborate with Quality, R&D, Regulatory, Source, Plan, and Operations.
• Facilitate collaboration with internal and external partners; resolve issues; mitigate risks.
• Review and approve technical documentation, IQ/OQ/PQ, validation activities.
• Manage asset decommissioning and coordinate disposition with partners.

Skills

Cross-functional leadership

Communication

Project leadership

Education

Bachelor of Mechanical Engineering

Tools

PLM

Windchill

Job description

Must Have Technical/Functional Skills

• A degree level or similar qualification experience in manufacturing engineering in orthopedics (metal implants) that can lead lifecycle management technical projects with our external manufacturing partners and suppliers.
• Minimum 5 years of hands‑on experience in medical device quality systems in various operational tasks of quality systems
• Knowledgeable in medical device FDA, MDD and MDR GMP requirements.
• Experience leading cross‑functional teams is required
• The candidate will need to be an effective communicator, capable of working with both external partners with external partners and internal cross functions, facilitating discussions, and navigating through challenges. Ideally, this individual would serve as both a project lead and technical lead.

Roles & Responsibilities

• Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners ensuring projects are completed on schedule, within scope, and in accordance with business objectives.
• Provide technical oversight and project leadership for external manufacturing partners. Assess and develop project scope, business case and technical feasibility and ensure effective implementation in alignment with business, quality, and regulatory requirements.
• Utilise business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities.
• Partner with and lead with cross functional teams including Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations to execute supply chain priorities, change requests and project deliverables.
• Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operations risks, and maintain customer service commitments.
• Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems.
• Manage Asset Decommissioning disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.

Salary Range: $90,000-$95,000 a year

TCS Employee Benefits Summary:

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinanc ing.

Location

West Chester, PA

Function

TECHNOLOGY

Role

Engineer

ID

435668

Skills

PLM | Windchill

Salary Range

$90,000 - $95,000

Desired Candidate Profile

Qualifications

Bachelor of Mechanical Engineering