Process Engineer

Description

• Maintain engineering files with documents including DOE reports, process sheets, and water diagrams.
• Lead continuous improvement projects.
• Author and execute test and validation protocols to comply with ISO and FDA medical device regulation requirements.
• Perform failure investigations utilizing problem-solving techniques and statistical methods to identify root causes and enact corrective actions.
• Collaborate with the quality group to validate injection molding processes using sound statistical methods.
• Maintain and promote a safe and clean working environment.
• Develop robust injection molding processes utilizing scientific molding techniques such as gate freeze analysis and short shot analysis.
• Verify documents are correctly filled out prior to set-up sign-off.
• Provide training and coaching to peers and Process Technicians.
• Follow all applicable safety procedures and guidelines as outlined in the company safety manual.

Requirements

• Strong troubleshooting and process engineering skills.
• Proficiency in scientific injection molding techniques such as IQ, OQ, PQ.
• Ability to lead projects and mentor team members.
• Experience in continuous improvement, lean manufacturing, and Six Sigma methodologies.
• Minimum of 3 years of experience with IQ, OQ, PQ.
• Minimum of 3 years of experience with validations and documentation.
• Experience with molding machines, tooling, and plastics injection molding.
• Minimum of 3 years of experience with Injection Molding.
• Understanding of statistical methods for process validation.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Saint Paul,MN. Application Deadline This position is anticipated to close on Dec 19, 2025.
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance