Senior Product Lifecycle Engineer (Medical Devices)

Role Description

• 7+ years of engineering experience in the medical device 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
  • Change management
  • Risk management
  • Process validation
  • Quality system compliance

Must-Have Technical/Functional Skills

• Strong expertise in:
  • Medical Device Product Lifecycle Management (PLM)
  • Design Controls
  • Engineering Change Management (ECO/ECN/ECR)
• Hands-on experience with:
  • Design Verification & Validation (V&V)
  • Test method development
  • Protocol development
  • Technical documentation
• Deep understanding of Risk Management methodologies:
  • ISO 14971
  • DFMEA
  • PFMEA
  • Hazard analysis
• Knowledge of:
  • Quality Management Systems (QMS)
  • ISO 13485
  • FDA 21 CFR Part 820/QMSR
  • Regulatory compliance requirements
• Experience in:
  • Supplier Quality Engineering
  • Component qualification
  • Supplier development
  • Design for Manufacturability (DFM)
• Proficiency in:
  • IQ/OQ/PQ process validation
  • 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 methodologies
• Excellent project management skills, including:
  • Project planning
  • Scheduling
  • Risk management
  • Stakeholder management
  • Cross-functional coordination
• Strong leadership, communication, and influencing skills with the ability to 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 activities:
  • Test planning
  • Test execution
  • Data review
  • Technical documentation
• Partner with manufacturing sites on:
  • IQ/OQ/PQ validation
  • Pilot builds
  • Validation builds
  • Production launch readiness
• Apply expertise in:
  • Design controls
  • Engineering change management
  • Risk management
  • Quality systems
  • Regulatory compliance
• Review:
  • Engineering drawings
  • Specifications
  • GD&T requirements
  • Tolerance analyses
  • Component acceptance criteria
• Drive:
  • Root cause analysis
  • Technical problem solving
  • Timely issue resolution
• Communicate:
  • Project status
  • Risks
  • Decisions
  • Recommendations to stakeholders and senior leadership
• Demonstrate:
  • Ownership
  • Accountability
  • Urgency
  • Ability to influence without direct authority

Generic Managerial Skills

• Strong verbal and written English communication skills.
• Ability to understand customer requirements and respond accurately.
• Excellent multitasking and prioritization skills.
• Ability to work effectively in a fast-paced environment.
• Ability to understand and follow complex written procedures.
• Strong teamwork and collaboration skills.
• Sound decision-making and analytical problem-solving abilities.
• Good situational judgment and stakeholder management skills.