Manufacturing Engineer II: Validation & Process Optimization

Peli BioThermal Limited; Maple Grove (MN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

Medical/dental/vision coverage

401(k) with company match

Paid vacation and holidays

Wellness programs

Professional development

Job summary

Peli BioThermal seeks a Manufacturing Engineer II in Maple Grove, MN to improve processes, validate equipment, and support cross-functional teams in a fast-paced environment.

You will partner with Operations, Quality, and Engineering to ensure safe, efficient production and adherence to quality standards while supporting new product introductions and process improvements. Travel up to 25% is required.

Qualifications

• Bachelor's Degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline.
• 3-5 years of manufacturing or engineering experience.
• Experience supporting equipment and process validation activities (IQ, OQ, PQ).
• Experience troubleshooting manufacturing equipment and production processes.
• Knowledge of Lean Manufacturing, continuous improvement, root cause analysis, or process improvement methodologies.
• Strong analytical, problem-solving, and organizational skills.
• Excellent communication skills with the ability to work across multiple departments.
• Comfortable working in a fast-paced manufacturing environment.
• Willingness and ability to travel up to 25%.

Responsibilities

• Support manufacturing process development, equipment optimization, and continuous improvement initiatives.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ.
• Assist with equipment installation, commissioning, process transfers, and manufacturing startup activities.
• Partner with Operations, Maintenance, Quality, and Engineering teams to troubleshoot issues.
• Support new product introductions by preparing manufacturing processes, documentation, and readiness.
• Analyze production data to identify trends and recommend process improvements.
• Create and maintain manufacturing documentation and SOPs.
• Participate in risk assessments, change control, and audit prep for regulatory compliance.
• Collaborate with global teams on engineering projects to improve performance across locations.
• Travel up to 25% to facilities, service centers, suppliers, and customer locations.

Skills

Lean Manufacturing

Continuous Improvement

Root Cause Analysis

Problem Solving

Analytical Skills

Communication Skills

Cross-Functional Collaboration

Education

Bachelor's Degree in Mechanical/Manufacturing/Industrial Engineering

Job description

Peli BioThermal seeks a Manufacturing Engineer II in Maple Grove, MN to improve processes, validate equipment, and support cross-functional teams in a fast-paced environment.

You will partner with Operations, Quality, and Engineering to ensure safe, efficient production and adherence to quality standards while supporting new product introductions and process improvements. Travel up to 25% is required.