Process Engineer

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

This range is provided by The Davis Companies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $65.00/hr

Direct message the job poster from The Davis Companies

The Process Engineer will take ownership of manufacturing and packaging process leadership—evaluating current systems, identifying areas for improvement, and driving initiatives that enhance efficiency, quality, and compliance. This role requires a self-starter with strong process validation experience, a continuous improvement mindset, and the confidence to lead cross-functional initiatives in a regulated medical device environment.

Key Responsibilities:

• Lead process improvement efforts across manufacturing and packaging operations to optimize quality, performance, and throughput.
• Assess current processes, identify root causes of inefficiencies, and implement data-driven solutions.
• Plan, execute, and document IQ/OQ/PQ validations in compliance with FDA and ISO 13485 requirements.
• Partner with Regulatory and Quality teams to evaluate process changes and ensure full regulatory compliance.
• Provide engineering support for process changes related to new product introductions, packaging redesign, and manufacturing transfers.
• Use CAD tools to support packaging redesigns, equipment layouts, and process documentation.
• Lead cross-functional teams in implementing continuous improvement and lean manufacturing initiatives.
• Prepare and maintain technical documentation, including protocols, reports, and risk analyses.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of experience in process engineering within a medical device (Class III preferred) or similarly regulated manufacturing environment.
• Proven experience with IQ/OQ/PQ validations and process documentation.
• Strong understanding of FDA regulations, ISO 13485, and GMP principles.
• Demonstrated success leading continuous improvement or lean manufacturing projects.
• Excellent analytical, communication, and project management skills.
• CAD proficiency (SolidWorks or equivalent) preferred.
• Must be self‑motivated, proactive, and capable of driving initiatives independently.

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Engineering and Manufacturing

Job location

Brooklyn Park, MN