Senior Medical Device Process & Validation Engineer

Intellectt INC; Minnetonka (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt INC in Minnetonka, MN is seeking a Sr. Manufacturing Engineer with medical device expertise. You will develop and optimize manufacturing processes, lead validation activities (IQ/OQ/PQ), and drive continuous improvement across production lines.

The role requires hands-on experience with PFMEAs, data analysis in Minitab, and strong knowledge of FDA/ISO 13485 GMP. Collaboration with cross-functional teams is essential to meet regulatory and quality standards.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• 4–5+ years of experience in Manufacturing Engineering within the medical device industry.
• Strong experience with Process Validation including IQ, OQ, and PQ.
• Experience developing, characterizing, and optimizing manufacturing processes.
• Experience developing and working with PFMEAs.
• Experience with data analysis using Minitab.
• Knowledge of Design for Manufacturability (DFM) principles.
• Experience with Lean Manufacturing and Continuous Improvement.
• Strong Root Cause Analysis and problem-solving skills.
• Experience with tooling, fixtures, and equipment design.
• Ability to troubleshoot production processes and provide equipment support.
• Knowledge of FDA regulations, ISO 13485, GMP, and applicable quality systems.
• Strong verbal and written communication skills.
• Ability to work effectively both independently and as part of a team.
• Strong organizational, multitasking, follow-up, and time-management skills.
• Ability to work in a fast-paced and changing environment while meeting deadlines.

Responsibilities

• Develop and optimize manufacturing processes for medical devices.
• Lead process development, validation activities (IQ/OQ/PQ), and continuous improvement projects.
• Create and maintain PFMEAs and perform risk analyses to minimize failures.
• Analyze data with Minitab to drive process capability and quality.
• Collaborate with design, regulatory, and manufacturing teams to ensure product manufacturability.
• Troubleshoot production issues and provide effective equipment support.

Skills

Manufacturing Process Development

Process Validation IQ OQ PQ

PFMEA and Risk Analysis

Lean Manufacturing and CI

Root Cause Analysis

Minitab

Design for Manufacturability

Tooling, Fixture, Equipment Design

Production Troubleshooting

FDA ISO 13485 GMP

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Minitab

Job description

Intellectt INC in Minnetonka, MN is seeking a Sr. Manufacturing Engineer with medical device expertise. You will develop and optimize manufacturing processes, lead validation activities (IQ/OQ/PQ), and drive continuous improvement across production lines.

The role requires hands-on experience with PFMEAs, data analysis in Minitab, and strong knowledge of FDA/ISO 13485 GMP. Collaboration with cross-functional teams is essential to meet regulatory and quality standards.