Senior Engineer Medical Device Lifecycle / Product Development

• Job Title: Senior Engineer – Medical Device Lifecycle / Product Development
• Location: Blue Ash, OH
• Duration: 6 months
• GBaMS ReqID: 10943418
• Experience Required: 6–8 years
• Essential Skill: Senior Engineer
• Skills: EIS – New Product Development (NPD) Methodology & Management; EIS – MDD Risk Management

Experience Requirements

• 7+ years of engineering experience in medical devices or other regulated industries.
• Experience leading cross-functional technical projects.
• Experience with:
  • Component development
  • Supplier qualification
  • Design verification
  • Manufacturing validation
• Strong understanding of:
  • Design controls
  • Engineering change management
  • Risk management
  • Process validation
  • Quality system compliance

Must-Have Technical Skills

• Strong expertise in Medical Device Product Lifecycle Management (PLM).
• Strong knowledge of Design Controls.
• Hands-on experience with ECO/ECN/ECR and Engineering Change Management.
• Experience with Design Verification & Validation (V&V).
• Experience developing:
  • Test methods
  • Test protocols
  • Technical documentation
• Strong knowledge of Risk Management, including:
  • ISO 14971
  • DFMEA
  • PFMEA
  • Hazard analysis
• Knowledge of Quality Management Systems (QMS).
• Knowledge of:
  • ISO 13485
  • FDA 21 CFR Part 820 / QMSR
  • Regulatory compliance requirements
• Experience with Supplier Quality Engineering (SQE).
• Experience in:
  • Component qualification
  • Supplier development
  • Design for Manufacturability (DFM)
• Proficiency in Process Validation, including:
  • IQ/OQ/PQ
  • Pilot builds
  • Validation builds
  • Manufacturing transfer
• Ability to interpret:
  • Engineering drawings
  • GD&T
  • Tolerance stack-ups
  • Specifications
  • Acceptance criteria
• Strong root cause analysis and problem-solving skills using:
  • 8D
  • CAPA
  • 5 Why
  • Fishbone
  • Corrective action processes
• Strong project management skills, including:
  • Planning
  • Scheduling
  • Risk management
  • Stakeholder management
  • Cross-functional coordination
• Strong leadership and communication skills.
• Ability to influence and drive decisions without direct authority.

Roles & Responsibilities

• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Develop and manage:
  • Project plans
  • Timelines
  • Risk mitigation strategies
  • Implementation readiness
• Coordinate cross-functional teams across:
  • Engineering
  • Quality
  • Regulatory
  • Manufacturing
  • Supply Chain
  • Procurement
  • Operations
  • External suppliers
• Serve as the technical interface with suppliers for:
  • Component development
  • DFM reviews
  • Tooling readiness
  • Process capability
  • Component qualification
• Support Design Verification & Validation (V&V) activities, including:
  • Test planning
  • Test execution
  • Data review
  • Technical documentation
• Partner with manufacturing sites on process validation, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
• Apply design controls, engineering change management, risk management, QMS requirements, and regulatory knowledge.
• Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
• Drive root cause analysis and technical problem-solving.
• Ensure timely closure of project issues.
• Communicate project status, risks, decisions, and recommendations to stakeholders and senior leadership.
• Demonstrate strong ownership, urgency, accountability, and influence.

Generic Managerial / Soft Skills

• Excellent English communication skills – reading, writing, and speaking.
• Ability to multitask and understand customer requirements.
• Ability to respond promptly and accurately.
• Strong prioritization skills in a fast-paced environment.
• Ability to understand and follow complex written procedures.
• Effective teamwork and collaboration.
• Strong decision-making and problem-solving abilities.
• Sound situational judgment.

Key Resume Keywords

• Senior Engineer
• Medical Device
• Product Lifecycle Management (PLM)
• Design Controls
• Engineering Change Management
• ECO / ECN / ECR
• Design Verification & Validation (V&V)
• ISO 14971
• DFMEA / PFMEA
• Hazard Analysis
• ISO 13485
• FDA 21 CFR Part 820
• QMS / QMSR
• Supplier Quality Engineering
• Supplier Qualification
• Component Development
• Component Qualification
• Supplier Development
• DFM
• IQ/OQ/PQ
• Process Validation
• Manufacturing Transfer
• Pilot Builds
• Validation Builds
• GD&T
• Tolerance Stack-Up
• Root Cause Analysis
• 8D
• CAPA
• 5 Why
• Fishbone
• New Product Development (NPD)
• Risk Management
• Cross-Functional Project Management
• Regulated Industry Experience