Medical Device Component Development Engineer
Full-time
PB consulting
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
Vacancy posted 29 days ago
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