Manufacturing Engineer II — Process & Validation

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

Benefits offered by this job

Annual bonus

Medical/dental/vision

401(k) match

Paid time off

Wellness programs

Employee assistance

Professional development

Hands-on equipment

Travel opportunities

Career growth

Job summary

Peli BioThermal is seeking a Manufacturing Engineer II in Maple Grove, MN. You will support process development, validation activities, equipment installation, and cross‑functional problem solving to drive quality and efficiency.

The role involves new product introductions, data-driven improvements, and creating essential SOPs and documentation. Travel up to 50% is required; strong collaboration across locations is expected.

Qualifications

• 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 communication and organizational skills.

Responsibilities

• Support manufacturing process development and equipment optimization.
• Develop and execute IQ, OQ, PQ validation activities.
• Assist with equipment installation, commissioning, process transfers, and startup activities.
• Collaborate with Operations, Maintenance, Quality, and Engineering teams to troubleshoot issues.
• Support new product introductions by preparing manufacturing processes and documentation.
• Analyze production data to identify trends and drive improvements.
• Create and maintain manufacturing documentation, SOPs, and validation protocols.
• Participate in risk assessments, change controls, and audit preparations.
• Collaborate with global teams on engineering projects across locations.
• Travel up to 50% to facilities, service centers, suppliers, and customers.

Skills

IQ/OQ/PQ experience

Equipment troubleshooting

Lean manufacturing

Analytical skills

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering

Job description

Peli BioThermal is seeking a Manufacturing Engineer II in Maple Grove, MN. You will support process development, validation activities, equipment installation, and cross‑functional problem solving to drive quality and efficiency.

The role involves new product introductions, data-driven improvements, and creating essential SOPs and documentation. Travel up to 50% is required; strong collaboration across locations is expected.