We're looking for an experienced engineer to support product and process development from prototype to full-scale manufacture. You'll work with internal design teams, material suppliers, and manufacturing partners to deliver high-quality, cost-efficient medical devices-right first time, every time. This is a hands-on role suited to someone who thrives on solving problems, managing suppliers, and driving technical excellence in fast-paced development environments. Key Deliverables Partner with R&D and manufacturing teams to ensure designs are optimized for manufacturability and assembly (DFM/DFA). Translate critical-to-quality requirements into clear, manufacturable component specs. Evaluate and develop suppliers-materials, subassemblies, and finished devices-for capability and reliability. Lead prototype builds, process trials, and validation activities at supplier and pilot line level. Implement and refine inspection, test, and control strategies for components and finished goods. Drive yield, quality, and efficiency improvements through data-driven problem solving (e.g. Six Sigma, DMAIC). Identify risks and implement mitigation plans to safeguard quality, timelines, and cost. Support change control and compliance activities within a regulated medical device framework. Experience & Skills Degree in Mechanical, Biomedical, or related Engineering discipline. 5+ years in medical device development, process validation, or supplier engineering. Proven track record with external manufacturing and material suppliers. Strong understanding of process characterization, validation, and documentation. Hands-on experience with SolidWorks, prototyping, and design verification methods. Skilled in statistical tools, structured problem solving, and continuous improvement. Excellent communicator, capable of managing multiple priorities independently. Skills: Process Development Equipment Validation R&D Research & Development