Development Process Engineer

Title: Development Process Engineer Location: Plymouth, MN (100% Onsite) Duration: 3+ months Pay Range: $30/hr to $33/hr (On W2) Shift Time: 08:00am to 04:00pm

We 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 sponsorship .

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