Component Dev Engineer

Siri InfoSolutions Inc; Blue Ash (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Siri InfoSolutions Inc in Blue Ash, OH seeks a Component Dev Engineer onsite to lead high-priority lifecycle changes and coordinate cross-functional teams.

You will drive plans, support design verifications, and ensure manufacturing transfer readiness. This role emphasizes risk management, supplier development, and regulatory compliance in a medical device context.

Qualifications

• Must have hands-on PLM, design controls, ECO/ECN/ECR experience.
• Proven V&V, test method development, and documentation.
• Strong knowledge of ISO 14971, DFMEA, PFMEA.
• Familiar with ISO 13485, FDA 21 CFR Part 820.
• Experience with supplier quality, DFM.
• Process validation IQ/OQ/PQ, pilot runs.
• Ability to read GD&T and tolerances.
• Strong problem solving (8D, CAPA).
• Cross-functional leadership and project planning.

Responsibilities

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

Skills

PLM & DC

V&V Testing

Risk Management

QMS & Compliance

Supplier Quality

Process Validation

GD&T

Root Cause Analysis

Project Management

Leadership & Communication

Job description

Position: Component Dev Engineer

Locations: Blue Ash, OH (Onsite Position from day one)

Duration: Fulltime

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.