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.

If you’re interested, please click “Apply” button