Development Process Engineer

About the role

We are seeking a Development Process Engineer to support the design, development, and implementation of manufacturing processes and equipment for a regulated product environment in St. Paul, Minnesota. This 7-month contract role offers the opportunity to drive process improvements, support validation efforts, and collaborate across R&D, Quality, Manufacturing, and Supply Chain teams.

Responsibilities

• Lead the development and implementation of new manufacturing processes and equipment to support production goals and process improvements.
• Support equipment specification, acquisition, and validation activities for new and existing manufacturing needs.
• Use structured problem-solving methods to identify root causes and develop corrective and preventive actions.
• Plan and execute design of experiments, evaluate data, and present findings to cross-functional partners.
• Contribute to continuous improvement efforts focused on product quality, efficiency, and waste reduction.
• Create and maintain technical documentation such as SOPs, validation protocols, risk assessments, and safety instructions.
• Partner with cross-functional teams to support product development, scale-up, and technical decision-making.
• Provide training and guidance to technicians and junior engineering team members.
• Evaluate and recommend tools, materials, and technologies that can strengthen manufacturing capabilities.

Qualifications

Bachelor’s degree in engineering or a related discipline, along with 2–5+ years of relevant experience, or a master’s degree with 0–2 years of experience, or an equivalent combination of education and experience.

Skills

• Strong analytical thinking and problem-solving abilities.
• Proven technical writing skills with the ability to produce clear, accurate documentation.
• Ability to work independently while also contributing effectively in collaborative team settings.
• Excellent communication and presentation skills.
• Working knowledge of manufacturing systems, automation, and process control.
• Experience in the medical device industry, especially in catheter manufacturing or similar regulated environments (preferred).
• Familiarity with GMP, ISO 13485, and FDA requirements (preferred).
• Hands-on experience with process validation, DOE, and statistical analysis (preferred).