Medical Device Lifecycle / Risk Management Engineer :: Blue Ash, OH (Onsite)

HI

Hope you are doing well!

I have an urgent requirement with one of my clients. Please find the job details below and forward me your updated resume along with your contact details ajeet@realtekconsulting.net

Medical Device Lifecycle / Risk Management Engineer

Location :: Blue Ash, OH

Primary Domain

• Medical Devices
• Regulated Manufacturing
• Product Development / Lifecycle Engineering

Mandatory Skills

• Medical Device Product Lifecycle Management (PLM)
• Design Controls
• Engineering Change Management (ECO/ECN/ECR)
• Design Verification & Validation (V&V)
• Risk Management (ISO 14971)
• DFMEA / PFMEA / Hazard Analysis
• ISO 13485
• FDA 21 CFR Part 820 / QMSR
• Supplier Quality Engineering
• Component Qualification
• Design for Manufacturability (DFM)
• Process Validation (IQ/OQ/PQ)
• Manufacturing Validation & Transfer
• GD&T and Engineering Drawings
• Root Cause Analysis (8D, CAPA, 5 Why, Fishbone)
• Cross-functional Project Leadership

Preferred Skills

• New Product Development (NPD)
• Supplier Development
• Tooling Readiness
• Manufacturing Launch
• Pilot & Validation Builds

Responsibilities

• Lead lifecycle engineering change projects from concept to implementation.
• Manage project schedules, risks, and stakeholder communication.
• Coordinate Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, and suppliers.
• Support supplier qualification and component development.
• Execute Design Verification & Validation activities.
• Support IQ/OQ/PQ and manufacturing validation.
• Review engineering drawings, GD&T, and tolerance stack-ups.
• Perform risk assessments and ensure regulatory compliance.
• Drive CAPA and root cause investigations.
• Present project status and technical decisions to leadership.

Standards & Regulations

• ISO 14971
• ISO 13485
• FDA 21 CFR Part 820 (QMSR)
• Design Controls
• Quality Management Systems (QMS)

Ideal Candidate Background

Candidates should have experience as:

• Medical Device Project Engineer
• Product Development Engineer
• Sustaining Engineer
• Manufacturing Engineer (Medical Devices)
• Design Quality Engineer
• Supplier Quality Engineer
• NPI/NPD Engineer
• Lifecycle Management Engineer

Good Matching Industries

• Medical Devices
• Diagnostics
• Life Sciences
• Pharmaceutical Device Manufacturing
• Biomedical Engineering
• Regulated Manufacturing (FDA)

Red Flags

Candidates lacking the following are unlikely to be a good fit:

• Medical device industry experience
• ISO 14971 risk management
• ISO 13485/FDA quality systems
• Design Controls
• V&V experience
• IQ/OQ/PQ validation