Lead Manufacturing Engineer

Job Summary


Responsibilities

• Execution of transfer, localization, and integration projects. Coordinate with Product Management, Operations, RA/QA, Supply Chain, RD, and external partners to achieve project success.
• Define manufacturing equipment requirements and collaborate with internal teams and external machine builders to deliver solutions that support business growth and scalability.
• Resolve issues related to fixtures, tooling, parts, and manufacturing systems to minimize impact on productivity, On-Time Delivery (OTD), and takt time.
• Design, develop, and optimize robust manufacturing processes for existing products, and product enhancements, along with maintaining the process risk assessments and documentation, including pFMEA.
• Lead process validation, equipment qualification, and scale-up from pilot to full production.

Requirements

• Bachelor's degree in Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field with 7+ years in manufacturing engineering within a GMP environment. Knowledge of global medical device regulatory requirements and working in regulated and non-regulated product environments. Knowledge of relevant quality systems (e.g., ISO 13485, etc.).
• Hands-on experience with global transfers, localization, integration, or complex launch programs, including process development improvement, validation, and equipment qualification. Ability to run multiple projects simultaneously. Proven success driving Lean Manufacturing, Six Sigma and other initiatives.
• Strong experience in manufacturing processes such as assembly, machining, fabrication, industrial automation, and inspection.
• Excellent team-building, coaching, and analytical skills with a data-driven approach to decision-making. Experienced practitioner in TPM / PPM culture and OEE improvement.
• Strong verbal and written communication abilities, capable of conveying complex technical concepts to varied audiences.

Language

• Fluency in English both written and verbal.

Travel

• Travel ~10% (Based on the business needs).

Preferred qualifications

• Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP).
• Proficiency in project management.
• Knowledge of AI/ML integration with automation.

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