Medical Device Component Development Engineer

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