Job Title:Development Process Engineer
Location: St. Paul, MN(onsite)
Contract Duration: Contract until05/31/2027
Working hours:8:00 - 5:00
Total hours: 40
KEY 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.
REQUIRED QUALIFICATIONS
- 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.
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.
