Job Description (Essential Functions)Job Description (Essential Functions)Lead the full lifecycle (development, prototyping, industrialization, documentation, and release) of custom tools and fixtures required to service advanced complex electronic and mechanical medical devices.Partner with the dedicated Service Team to identify equipment needs, implement design improvements, and optimize service equipment workflows for efficient repair operations.Develop all required engineering documentation for tool release, including comprehensive assembly instructions, mechanical drawings, Bills of Materials (BOMs), and formal validation reports.Drive the formal release of service tools into the Document Control System, managing their industrialization to ensure readiness for successful global deployment across multiple technical centers.Support the rigorous qualification, verification, and validation (IQ/OQ/PQ) of all service tools in strict accordance with medical device regulatory and quality system requirements (e.g., ISO 13485, FDA).
1-4 years
Preferred Skills & KnowledgeFamiliarity with manufacturing process development, validation, and documentation in a tightly controlled quality system environment.Experience in process improvement and cost reduction initiatives, contributing to overall global service readiness and efficiency.Basic knowledge of Lean Manufacturing concepts such as Design for Manufacturing (DFM), Design of Experiments (DOE), and product/process Failure Mode and Effects Analysis (FMEA).Excellent communication and cross-functional collaboration skills to effectively work with R&D, Production Engineering, Procurement, and external suppliers.Experience collaborating with internal manufacturing resources and external vendors to ensure timely delivery and high-quality fabrication of specialized service equipment.
Required Skills & ExperienceBachelor?s degree in Mechanical Engineering or a closely related technical discipline.3+ years of relevant experience in manufacturing engineering, product support, or tooling design?specifically within the medical device or other highly regulated industry.Demonstrated expertise with CAD software (SolidWorks preferred) and foundational knowledge of mechanical design principles and Geometric Dimensioning and Tolerancing (GD&T).Direct experience with electronics assembly, including computer interfaces, PC boards, enclosures, test software and mechanical devices.Proven ability to manage multiple simultaneous projects under tight delivery timelines while maintaining robust documentation and quality standards.
Bachelors
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