Pharma/Med Device Manufacturing Engineer — FDA Remediation

S4 Analytics LLC; Virginia (MN); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading engineering firm is looking for experienced Manufacturing Engineers to support FDA-regulated medical device and pharmaceutical manufacturing in Virginia. Candidates should have 5–7 years of experience, particularly in automated settings, with a focus on quality management systems. Responsibilities include supporting operations, conducting risk assessments, and driving process improvements. The role requires a Bachelor's degree in Mechanical or Manufacturing Engineering and proficiency in AutoCAD and SolidWorks.

Qualifications

• 5–7 years of Manufacturing Engineering experience in FDA-regulated environments.
• Pharmaceutical high-speed fill-finish experience is required for the Virginia role.
• Hands-on experience with PFMEA, process risk analysis, and validation.

Responsibilities

• Support automated manufacturing operations in pharma/medical device environments.
• Conduct detailed process risk assessments and update PFMEAs.
• Ensure alignment between documented procedures and actual production practices.

Skills

Automated manufacturing experience

Quality Management Systems (QMS)

Process risk analysis

PFMEA

AutoCAD proficiency

SolidWorks proficiency

Knowledge of PLCs

Project management

Education

Bachelor’s degree in Mechanical or Manufacturing Engineering

Tools

AutoCAD

SolidWorks

Job description

A leading engineering firm is looking for experienced Manufacturing Engineers to support FDA-regulated medical device and pharmaceutical manufacturing in Virginia. Candidates should have 5–7 years of experience, particularly in automated settings, with a focus on quality management systems. Responsibilities include supporting operations, conducting risk assessments, and driving process improvements. The role requires a Bachelor's degree in Mechanical or Manufacturing Engineering and proficiency in AutoCAD and SolidWorks.