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Position Title:

Development Process Engineer Work Location:

St. Paul, MN, USA, 55117

Assignment Duration:

7+ months

Work Schedule:

8:00 AM - 5:00

PM Work Arrangement:

Onsite Position Summary:

Lead the design, development, and implementation of new manufacturing processes and equipment. Specify, acquire, and validate new equipment to support production and process improvements.

Key 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.
• Develop and implement 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. Qualification & Experience
• Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 2-5+ years of relevant experience OR master's degree with 0-2 years of experience or an equivalent combination of education and 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 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.