Manufacturing Engineer

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.
• Strong knowledge of Quality Management Systems (QMS).
• Hands-on PFMEA, process risk analysis, and validation experience.

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.
• Evaluate and implement mitigation controls across manufacturing processes.
• Support validation activities including IQ, OQ, PQ, and TMV.
• Review and update SOPs, Work Instructions, and DHF documentation.
• Ensure alignment between documented procedures and actual production practices.
• Drive process improvements and remediation activities.
• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering).
• Support dimensional inspection, detection systems, capital equipment, and electromechanical assemblies.

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

Manufacturing Engineer (Pharma / Medical Device)

• Delaware (12 Months – FDA 483 Remediation)

Job Summary

We are seeking experienced Manufacturing Engineers to support pharmaceutical and FDA-regulated medical device manufacturing operations. The roles will focus on high-speed fill-finish environments (Virginia) and FDA 483 remediation, process risk analysis, and validation support (Delaware).

Candidates must have strong hands-on experience in automated manufacturing environments, quality systems, and process improvement initiatives within regulated industries.

Key Responsibilities

• Support automated manufacturing operations in pharma/medical device environments
• Develop line layouts, fixture designs, and support 3D printing initiatives
• Conduct detailed process risk assessments and update PFMEAs
• Evaluate and implement mitigation controls across manufacturing processes
• Support validation activities including IQ, OQ, PQ, and TMV
• Review and update SOPs, Work Instructions, and DHF documentation
• Ensure alignment between documented procedures and actual production practices
• Drive process improvements and remediation activities
• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering)
• Support dimensional inspection, detection systems, capital equipment, and electromechanical assemblies

Required Qualifications

• Bachelor’s degree in Mechanical or Manufacturing Engineering
• 5–7 years of Manufacturing Engineering experience in FDA-regulated pharma or medical device environments
• Pharmaceutical high-speed fill-finish experience (Required for Virginia role)
• Strong knowledge of Quality Management Systems (QMS)
• Hands‑on experience with PFMEA, process risk analysis, and validation
• Experience in automated manufacturing environments
• Proficiency in AutoCAD and SolidWorks
• Basic understanding of PLCs and HMIs
• Experience managing small‑to‑mid scale engineering projects

Preferred Qualifications

• Experience with filling and capping equipment
• Prior FDA inspection or 483 remediation experience
• Background in capital equipment or electromechanical product manufacturing

Please feel free to reach me at + 1(469)-429-8065