Manufacturing Engineer Wire Harness
Job Description
Process Engineering and Strategic Design
System Design: Develop and optimize complex manufacturing workflows and workstation layouts using Lean Manufacturing methodologies.
Advanced CAD Design: Oversee and approve 3D/2D designs in SolidWorks for fixtures, lay boards, and high-precision component prototypes.
Technological Development: Define the strategic roadmap for connector applications and fine wire termination, evaluating new manufacturing technologies.
Project Management: Coordinate New Product Introduction (NPI) cycles from the initial design phase through to mass production.
Quality and Regulatory Compliance
Quality Leadership: Lead CAPA investigations and head multidisciplinary teams for the development and updating of Process FMEAs.
Validation Strategy: Design, approve, and oversee the execution of equipment and production line validation protocols (IQ/OQ/PQ).
Document Governance: Authorize Standard Operating Procedures (SOPs), technical drawings, and data analysis reports for regulatory audits.
Regulatory Assurance: Guarantee strict process compliance with ISO 13485, 21 CFR 820 standards, and IPC/WHMA-A-620 acceptability criteria.
Profile and Requirements
Education: Bachelor’s Degree in Electromechanical, Electrical, Industrial, Manufacturing Engineering, or related field.
Experience: 5+ years of experience as an engineer within the medical device industry. Proven track record in electromechanical assembly and wire harnesses.
Technical Knowledge: Advanced proficiency in SolidWorks. Deep expertise in line transfers and medical validation protocols. Expert use of statistical software (Minitab).
Languages: Advanced English proficiency B2+ to interface with global corporate clients and regulatory bodies.