Component Dev Engineer

Tata Consultancy Services; Blue Ash (OH); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Discretionary Annual Incentive

Comprehensive Medical Coverage

Family Support Leaves

401K Plan

Certification & Training Reimbursement

Vacation & Holidays

Legal & Financial Assistance

Job summary

Tata Consultancy Services in Blue Ash, OH is seeking a seasoned professional to lead medical device lifecycle projects, drive ECO/ECN processes, and ensure robust QA/QMS compliance.

The role demands expertise in PLM, V&V, risk management, GD&T, supplier quality, and cross-functional leadership to deliver design changes from concept to production readiness.

Qualifications

• Strong expertise in Medical Device PLM, Design Controls, and ECO/ECN/ECR.
• Hands-on Design Verification & Validation (V&V), test methods, protocol development, documentation.
• Deep understanding of Risk Management: ISO 14971, DFMEA, PFMEA, hazard analysis.
• Knowledge of QMS, ISO 13485, FDA 21 CFR Part 820/QMSR, regulatory compliance.
• Experience in Supplier Quality Engineering, component qualification, and DFM.
• Proficiency in Process Validation (IQ/OQ/PQ), pilot builds, manufacturing transfer.
• Ability to interpret drawings, GD&T, tolerances, specs, acceptance criteria.
• Strong root cause analysis using 8D, CAPA, 5 Why, Fishbone.
• Excellent project management including planning, scheduling, risk, stakeholder mgmt.

Responsibilities

• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation, and implementation readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
• Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
• Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
• Partner with manufacturing sites on process validation activities, IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
• Review engineering drawings, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis, technical problem solving, and timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations to stakeholders and senior leadership.
• Demonstrate ownership, urgency, accountability, and ability to influence without direct authority.

Skills

PLM

Design Controls

ECO/ECN/ECR

V&V

Risk Management

QMS/Regulatory

Supplier Quality

Process Validation

GD&T

Root Cause Analysis

Project Management

Leadership & Influence

cross-functional coordination

Education

Bachelor of Computer Science

Job description

• Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
• Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
• Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
• Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
• Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
• Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer.
• Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria.
• Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes.
• Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination.
• Effective leadership, communication, and influencing skills, with the ability to drive decisions and deliver results without direct authority.
• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
• Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
• Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
• Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis, technical problem solving, and timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
• Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Job Description

Must Have Technical/Functional Skills

• Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
• Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
• Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
• Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
• Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
• Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer.
• Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria.
• Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes.
• Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination.
• Effective leadership, communication, and influencing skills, with the ability to drive decisions and deliver results without direct authority.
• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
• Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
• Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
• Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis, technical problem solving, and timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
• Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Roles & Responsibilities

• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
• Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
• Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
• Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis, technical problem solving, and timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
• Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Generic Managerial Skills, If any

• Strong communication skills, with proficiency in reading, writing, and speaking English.
• Ability to multitask, understand customer requirements, and respond promptly and accurately.
• Capability to prioritize and manage multiple tasks in a fast‑paced environment.
• Ability to understand and follow complex written procedures.
• Ability to work effectively in a team environment and contribute to team goals.
• Strong decision‑making and problem‑solving abilities with sound situational judgment.

Salary Range

Salary Range: $70,000 -$80,000 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 Refinancing.

Qualifications

BACHELOR OF COMPUTER SCIENCE