Manufacturing Engineer II

Job Title: Manufacturing Engineer II

Location: St. Paul, MN (100% Onsite)

Position Summary

The Manufacturing Engineer II will support quality system integration activities, documentation updates, equipment qualification, and manufacturing process improvements within a regulated manufacturing environment. This role requires strong documentation skills, attention to detail, and experience with validation and manufacturing operations.

Key Responsibilities

• Review and update manufacturing and quality documentation, SOPs, and protocols.
• Support quality system integration and compliance initiatives.
• Maintain process documentation, control plans, risk assessments, and work instructions.
• Support equipment qualification activities (IQ/OQ/PQ).
• Assist with manufacturing line transfers, moves, and duplication projects.
• Identify technical issues and support implementation of effective solutions.
• Collaborate with cross-functional teams on validation and process improvement activities.

Required Qualifications

• Bachelor's degree in Mechanical, Electrical, Software, Manufacturing, or related Engineering discipline.
• 3–5 years of Manufacturing Engineering experience.
• Strong documentation review and technical writing skills.
• Experience in a regulated manufacturing environment.
• Knowledge of manufacturing processes, validation, and quality systems.

Preferred Qualifications

• Experience supporting quality system integration projects.
• Hands-on experience with IQ/OQ/PQ activities.
• Experience with equipment qualification, line transfers, or manufacturing line moves.
• Experience within medical device, life sciences, or other highly regulated industries.

Key Skills

• Manufacturing Engineering
• Quality Systems (QMS)
• IQ/OQ/PQ Validation
• SOP & Process Documentation
• Risk Assessment
• Equipment Qualification
• Process Improvement
• Attention to Detail