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.