Component Dev Engineer

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.

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: $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.

#LI-SP1

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Role: Engineer

Desired skills: Medical Device NPD | PLM

Qualifications: BACHELOR OF COMPUTER SCIENCE

• Experience: 6 - 12 Years

• Job function: TECHNOLOGY

• Location: Blue Ash, OH

Salary range: $70,000–$80,000

Apply by: 2026-09-28 00:00:00