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.

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.

• 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.

• Bachelor’s degree in engineering (Mechanical, Biomedical, Chemical, or related field) with0-2+ yearsof 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.

• Experience in the medical device industry, particularly withcatheter manufacturingor similar regulated environments.
• Familiarity withGMP,ISO 13485, andFDA regulations.
• Hands‑on experience withprocess validation,DOE, and statistical analysis.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click Apply button