Job Description

We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ideal candidate will have expertise in design controls, verification & validation, supplier quality, process validation, and regulatory compliance.

Roles and Responsibilities

• Lead component development and engineering change projects from concept to implementation.
• Manage project timelines, risks, and cross-functional coordination.
• Support Design Verification & Validation (V&V), test protocols, and technical documentation.
• Partner with suppliers on component qualification, DFM reviews, tooling, and process capability.
• Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness.
• Apply Design Controls, PLM, ECO/ECN/ECR, Risk Management, and Quality System requirements.
• Review engineering drawings, GD&T, specifications, and acceptance criteria.
• Drive root cause analysis using CAPA, 8D, 5 Whys, and Fishbone methodologies.
• Communicate project status, risks, and technical recommendations to stakeholders.

Required Qualifications

• Experience in Medical Device Component Development or Product Development.
• Strong knowledge of:
  • Product Lifecycle Management (PLM)
  • Design Controls & Engineering Change Management (ECO/ECN/ECR)
  • Design Verification & Validation (V&V)
  • ISO 14971, DFMEA, PFMEA
  • ISO 13485 & FDA 21 CFR Part 820/QMSR
  • Supplier Quality Engineering & Design for Manufacturability (DFM)
  • Process Validation (IQ/OQ/PQ)
  • GD&T and engineering drawings
• Strong project management, communication, and problem-solving skills.
• Experience working with cross-functional teams in a regulated medical device environment.

Preferred Skills

• Medical Device Product Development
• Supplier Quality & Component Qualification
• Risk Management & Regulatory Compliance
• Manufacturing Transfer & Validation
• Root Cause Analysis (CAPA, 8D)
• Stakeholder & Project Management

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