Process Engineer, Medical Devices | Lean & Validation Focus

The Davis Companies; Brooklyn Park (MN); On-site; USD 82,656 - 89,544; Full time

Job summary

A reputable engineering firm is seeking a Process Engineer to lead improvements in manufacturing and packaging processes. This role requires a minimum of 5 years of experience in a regulated environment, expertise in process validations, and the ability to drive continuous improvements. Candidates should hold a relevant engineering degree and be skilled in CAD tools. The position is based in Brooklyn Park, MN.

Qualifications

• 5+ years of experience in process engineering within a medical device or regulated manufacturing environment.
• Proven experience with IQ/OQ/PQ validations and process documentation.
• Strong understanding of FDA regulations, ISO 13485, and GMP principles.

Responsibilities

• Lead process improvement efforts across manufacturing and packaging operations.
• Assess current processes and implement data-driven solutions.
• Plan, execute, and document IQ/OQ/PQ validations in compliance with FDA and ISO 13485.

Skills

Process validation

Continuous improvement

Lean manufacturing

Analytical skills

Communication skills

Project management

CAD proficiency

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field

Tools

SolidWorks

CAD tools

Job description

A reputable engineering firm is seeking a Process Engineer to lead improvements in manufacturing and packaging processes. This role requires a minimum of 5 years of experience in a regulated environment, expertise in process validations, and the ability to drive continuous improvements. Candidates should hold a relevant engineering degree and be skilled in CAD tools. The position is based in Brooklyn Park, MN.