Development Process Engineer
Title: Development Process EngineerLocation: Plymouth, MN (100% Onsite)Duration: 3+ monthsPay Range: $30/hr to $33/hr (On W2)Shift Time: 08:00am to 04:00pmWe are looking for a "Development Process Engineer"to join one of our Fortune 500 clients.Job Summary:Seeking a Process Development Engineer to join our dynamic team at our Plymouth, MN facility. This role is ideal for an engineer who thrives in a hands-on, fast-paced environment and is passionate about driving innovation, improving manufacturing processes, and ensuring product quality in a regulated industry.As a Process Development Engineer I, you will play a critical role in the development, optimization, and validation of manufacturing processes. Your work will directly impact product quality, operational efficiency, and regulatory compliance.Job Responsibilities:Process Development & Implementation:Lead the design, development, and implementation of new manufacturing processes and equipment.Specify, acquire, and validate new equipment to support production and process improvements.Problem Solving & Root Cause Analysis:Apply structured problem-solving methodologies to identify root causes of process issues.Develop and implement corrective and preventive actions (CAPAs).Data-Driven Improvements:Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams.Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency.Documentation & Compliance:Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions.Ensure all processes comply with internal quality systems and external regulatory requirements.Cross-Functional Collaboration:Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up.Provide technical training and mentorship to technicians and junior engineers.Innovation & Technical Leadership:Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.Support tooling development and process validation for new and existing products.Education:Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 0-2+ years of relevant experience.Strong analytical and problem-solving skills.Proficiency in technical writing and documentation.Ability to work independently and collaboratively in cross-functional teams.Excellent communication and presentation skills.Working knowledge of manufacturing systems, automation, and process control.Preferred Qualifications:Experience in the medical device industry, particularly with catheter manufacturing or similar regulated environments.Familiarity with GMP, ISO 13485, and FDA regulations.Hands-on experience with process validation, DOE, and statistical analysis.We are looking for the candidate who are eligible to work with any employers without sponsorshipIf you're interested, please click "Apply" button