Process Development Engineer II

This opportunity is with a fast growing organization based out of Minneapolis looking to add to their engineering department. You will develop, optimize, and transfer manufacturing processes supporting new product introductions and process improvements. You will collaborate with R&D, Quality, Manufacturing, and Supply Chain to deliver robust, scalable, and compliant production processes within a regulated medical device environment.

• Develop and optimize processes for manufacturing
• Create and maintain technical documentation, including DHRs, work instructions, and process records.
• Serve as the technical liaison for customers, providing engineering support and process expertise.
• Lead validation activities, DOE studies, data analysis, and statistical reporting.
• Support NPI through process development, scale-up, and manufacturing transfer.
• Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective actions.
• Drive continuous improvement using Lean, Six Sigma, or similar methodologies.

• Bachelor's degree in Engineering (Mechanical, Chemical, Materials, Industrial, or related).
• 3–5 years of process, manufacturing, or process development engineering experience.
• Experience with process validation, DOE, statistical analysis, and root cause investigations.
• Strong technical communication and cross-functional collaboration skills.
• Knowledge of ISO 13485, FDA, GMP, Lean Manufacturing, and Six Sigma preferred