Process Development Engineer

6-month Contract Onsite in Plymouth, MN Must be able to work on a W2 Key Responsibilities Process Development & Implementation: Lead the conceptualization, design, and deployment of new manufacturing processes and equipment. Specify, acquire, and validate new tools to enhance productivity and product quality.Root Cause Analysis & Problem Solving: Utilize structured methodologies to diagnose process issues, identify root causes, and develop robust corrective and preventive actions (CAPAs) to ensure process stability.Data-Driven Improvements: Plan and conduct Design of Experiments (DOE), analyze data effectively, and communicate insights to cross-functional teams. Spearhead continuous improvement initiatives to reduce waste, improve yields, and increase efficiency.Documentation & Compliance: Create, review, and maintain comprehensive technical documents, including Standard Operating Procedures (SOPs), risk assessments, validation protocols, and safety guidelines, ensuring compliance with internal standards and regulatory requirements.Cross-Functional Collaboration: Partner closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development, process scale-up, and technology transfer. Provide technical training and mentorship to technicians and junior engineers.Innovation & Technical Leadership: Evaluate emerging materials, tools, and technologies to advance manufacturing capabilities. Support tooling development, process validation, and process transfer activities. Qualifications: Bachelor’s degree in Mechanical, Biomedical, Chemical, or related engineering discipline; Master’s degree with 0-2 years of relevant experience or equivalent combination of education and experience.2-5 years of industry experience, preferably in medical device manufacturing or a regulated environment.Strong analytical mindset with excellent problem-solving skills.Proficiency in technical documentation, validation, and process control.Ability to work independently and collaboratively within cross-disciplinary teams.Excellent communication skills, with the ability to present complex technical information clearly.Working knowledge of manufacturing automation, process control, and validation techniques. Preferred Skills & Experience: Experience with catheter manufacturing or similar regulated medical technologies.Familiarity with GMP, ISO 13485, and FDA regulations.Hands-on experience with process validation, DOE, and statistical analysis tools.