Manufacturing Process Engineer

Responsibilities

Maintain and continuously improve established manufacturing processes, tooling, and semi-automated systems.

Own equipment performance, reliability, and long-term sustainability.

Troubleshoot mechanical and electrical issues using structured root cause methodologies.

Drive equipment and process improvements, including error-proofing and uptime optimization.

Execute validation activities (IQ/OQ/PQ) and maintain technical documentation.

Ensure compliance with FDA, ISO, and internal quality system requirements.

Support CAPA, nonconformance investigations, and audit readiness.

Provide real-time production support and drive continuous improvement initiatives.

Train and guide technicians and operators on processes and equipment.

Requirements

• Bachelor's degree in mechanical, Electrical, or related Engineering discipline.
• 2+ years of engineering experience in a regulated manufacturing environment.
• Hands-on experience with mechanical systems, equipment, and tooling.
• Electrical troubleshooting and controls fundamentals.
• Experience supporting or owning semi-automated manufacturing equipment.
• Strong problem-solving and root cause analysis capability.
• Medical device manufacturing experience.
• Experience with validation processes (IQ/OQ/PQ) and quality systems.
• Leverage Lean / Six Sigma experience.
• Exposure to manufacturing systems (e.g., MES, SAP).
• Basic familiarity with automated equipment and controls.

Key Competencies

• Technical problem solving
• Track record of resolving technical problems using critical thinking skills and proven methodologies (6-step problem-solving, DMAIC, etc.)
• Cross-functional collaboration
• Ownership and accountability
• Continuous improvement mindset
• Willingness to learn and improve oneself, their team, and their production unit
• Ability to learn quickly
• Willingness to fail fast and learn from mistakes
• Willingness to quickly and correctly apply new learnings