NPI Process Engineer

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.