Process Engineer

Process Engineer

Location: Maple Grove, MN

Onsite

Pay: $68.00 per hour

Contract: 6 months (to start)

Work Authorization: Applicants must be authorized to work in the U.S. without current or future visa sponsorship.

Position Overview

We are seeking an experienced Process Engineer to lead clinical build line operations and process development activities supporting product commercialization. This role is responsible for owning critical process development and validation deliverables, characterizing manufacturing processes, and driving cross-functional execution in a regulated environment.

The ideal candidate brings strong technical depth, hands-on manufacturing experience, and the ability to lead complex engineering initiatives from development through production.

Key Responsibilities

Process Development & Commercialization

• Lead clinical build line activities and support commercialization readiness
• Own process development deliverables, including process characterization and process validation documentation
• Apply Six Sigma, process studies, and continuous improvement methodologies to optimize manufacturing processes

Cross-Functional Collaboration

• Partner closely with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success
• Lead and contribute to new product development and product support teams

Engineering Analysis & Problem Solving

• Develop innovative technical solutions to complex manufacturing challenges
• Select and apply appropriate process improvement techniques to support sound equipment and process recommendations
• Design, coordinate, and evaluate complex engineering tests and experiments
• Summarize, analyze, and draw conclusions from complex test data

Documentation & Communication

• Prepare and deliver detailed technical reports, specifications, and presentations
• Communicate results effectively to technical and cross-functional stakeholders
• Assess feasibility and robustness of proposed process changes, equipment, and evaluation plans

Project & Equipment Management

• Coordinate, manage, and document project goals, timelines, and progress
• Lead and manage Capital Equipment Request Authorizations (CERAs)
• Drive production goals and support operational readiness

Leadership & Training

• Lead cross-functional project teams
• Train, mentor, and provide technical direction to operators, technicians, and engineers

Quality Systems

• Build quality into all work by ensuring compliance with applicable quality systems and regulatory requirements

Required Qualifications

• Bachelor's degree in Mechanical, Chemical, Biomedical Engineering, or related field
• 5+ years of process engineering experience in a manufacturing or regulated environment
• Strong experience with process validation, process characterization, and commercialization support

Preferred / Job-Specific Experience

• Knowledge of electropolishing processes
• Hands-on experience with Keyence and Sensofar measurement technologies
• Experience working in regulated industries (medical device, biotech, pharmaceutical preferred)

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

Interested? We have a fast, easy online application process. Click 'Apply Now,' and a recruiter will contact you soon!

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Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.