Development Process Engineer

About the role

Seeking a Process Development Engineer to join a dynamic team at a Fortune 500 client’s Plymouth, MN facility. This hands-on role focuses on driving innovation, improving manufacturing processes, and ensuring product quality in a regulated industry. The position is 100% onsite for a duration of 3+ months.

Responsibilities

• Lead the design, development, and implementation of new manufacturing processes and equipment.
• Specify, acquire, and validate new equipment to support production and process improvements.
• Apply structured problem-solving methodologies to identify root causes of process issues and develop corrective and preventive actions (CAPAs).
• 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.
• 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.
• 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.
• Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.
• Support tooling development and process validation for new and existing products.

Requirements

• 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.
• Eligible to work with any employer without sponsorship.

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.

Pay

$30/hr to $33/hr (On W2).

Schedule

08:00 AM to 04:00 PM, 100% onsite.