About this role
As the Industrial Engineering Director, you will lead manufacturing process design, ERP data integrity, and continuous improvement for hearing aid (or related medical device) manufacturing operations. This role bridges engineering, quality, operations, and regulatory functions to ensure efficient, compliant, and scalable manufacturing of miniaturized precision medical devices. In this role, you will be in charge of: ERP & Manufacturing Data Ownership Own Bill of Material (BOM) maintenance in ERP, ensuring accuracy and version control across all active products Set up and maintain Manufacturing Process routings and corresponding cycle times in ERP Ensure ERP data integrity supports accurate costing, capacity planning, and production scheduling Process Optimization & Productivity Own cycle time studies, line balancing, and cycle time reduction activities across assembly and sub-assembly operations Lead productivity, yield improvement, and scrap reduction initiatives across manufacturing lines Drive continuous improvement using Lean/Six Sigma methodologies for high-mix, low-volume precision assembly Engineering Change & Qualification Management Lead the Engineering Change Management (ECM/ECO) process, ensuring cross-functional review, impact assessment, and proper documentation Execute engineering qualification of alternate source components and manufacturing processes, ensuring form, fit, and function equivalence Partner with R&D and Value Engineering (VE) teams on design-for-manufacturability/assembly (DFM/A) reviews Quality & Regulatory Compliance Ensure manufacturing processes comply with ISO 13485 (QMS) and applicable regional medical device regulations (FDA 21 CFR 820, EU MDR) Lead or support Process FMEA, Process Validation (IQ/OQ/PQ), and Product Quality Investigations tied to manufacturing processes Maintain documentation and traceability to support audits and regulatory inspections Leadership & Cross-Functional Collaboration Manage a team of industrial/process/manufacturing engineers Partner with Operations, Supply Chain, R&D, and Quality on manufacturing roadmaps and NPI readiness Your background: Bachelor's or Master's degree in Industrial, Mechanical, or Manufacturing Engineering (or related) 8–10+ years in manufacturing/industrial engineering. Experience in medical device or precision electronics manufacturing will be an advantage Hands-on ERP experience (BOM structuring, routing setup, cycle time data management) — SAP, Oracle, or similar Deep knowledge of ISO 13485 and design controls under 21 CFR 820.30 / EU MDR Experience leading Engineering Change Management processes in a regulated environment Proven track record in cycle time reduction, line balancing, and yield/scrap improvement Experience with component/process qualification (alternate sourcing, second-source validation) Six Sigma or equivalent Lean certification will be preferred How we work: At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.