Senior Manufacturing Engineer – Lead Projects & Process Improvement

About the role

The Senior Manufacturing Engineer will lead engineering projects and provide technical support to ensure high‑quality, low‑cost production of medical devices. Reporting to senior management, the role oversees a small team and collaborates with cross‑functional value‑stream teams.

Key responsibilities

• Execute engineering assignments such as ECNs, NPEs, and LCNs independently.
• Manage product transfers, acquisitions, and integrations throughout the PTR/PAR process.
• Validate complex equipment and manufacturing lines, owning preventative maintenance and calibration.
• Partner with the Value Stream Team to meet capacity, scrap, and labor efficiency targets.
• Ensure compliance with FDA, OSHA, ISO, and corporate regulations.
• Assist equipment technicians in troubleshooting and perform investigations of EIRs/MIRs.
• Define and execute cost, quality, and capacity improvement programs.
• Collaborate with technical operations to modify part designs for better manufacturability.

Required profile

• Engineering degree in mechanical, electrical, chemistry, biomedical, microbiology or related field.
• 5–10 years of experience in a labor‑ and machine‑intensive manufacturing environment.
• Strong project‑management knowledge; PMP certification preferred.
• In‑depth understanding of equipment qualification, process validation, and medical‑device manufacturing (FDA GMP).
• Experience with lab and chemistry equipment such as weighing scales, mixing processes, and steam sterilizers is a plus.
• Six Sigma Green Belt (Black Belt preferred) and solid Lean Principles knowledge.
• Fluent in English and Spanish.

Required skills

• Project Management Professional (PMP) concepts
• Six Sigma Green Belt (Black Belt preferred)
• Lean manufacturing principles
• Equipment qualification and process validation
• Operation of lab/chemistry equipment (weighing scales, mixers, steam sterilizers)
• Microsoft Excel, Word, PowerPoint
• SolidWorks
• MiniTab