Senior Manufacturing Engineer

About the role

Laborie is seeking a Senior Manufacturing Engineer to lead the development, qualification, and launch of new drug‑device combination products and updates to existing medical devices. The role works across multiple functions to ensure efficient design transfer and continuous improvement in a lean manufacturing environment.

Key responsibilities

• Design manufacturing processes, procedures, and production layouts to optimize productivity, quality, and cost.
• Optimize drug coating, manufacturing, and packaging processes and drive platform‑wide improvements.
• Manage project plans, schedules, budgets, and risks using PMO fundamentals and report status to leadership.
• Lead line validation activities (IQ, OQ, MSA, PQ) including documentation, testing protocols, and summary reports.
• Participate in Lean initiatives to stabilize lines, reduce waste, and improve efficiency.
• Prepare technical documentation such as work instructions, control plans, job safety analyses, and process flow charts.
• Conduct PFMEA, DFMEA, process mapping, and Design for Manufacturing reviews.

Required profile

• Senior‑level experience in manufacturing engineering, preferably within medical device or pharmaceutical environments.
• Proven experience in lean manufacturing and cross‑functional project execution.
• Strong analytical mindset with ability to evaluate cost, labor, and material data.

Required skills

• Lean manufacturing
• Process validation (IQ, OQ, MSA, PQ)
• PFMEA and DFMEA
• Process mapping
• Design for Manufacturing (DFM)
• Project management (PMO fundamentals)
• Technical documentation creation (control plans, work instructions, safety analyses)
• Cost analysis and production scheduling