Job Description

We are seeking a highly skilled 5 Manufacturing Engineers to join our team, supporting the design, implementation, and validation of manufacturing processes for surgical products in the medical device industry. This is a critical role that involves working within cross-functional teams to improve product quality, reduce waste, and drive continuous improvement across manufacturing processes.

Key Responsibilities:

• Collaborate with Quality Assurance , Supplier Quality , Regulatory , Manufacturing , and Planning teams to ensure the smooth operation of manufacturing processes for surgical products .
• Design, develop, specify, and purchase tooling, fixtures , and equipment used in the manufacturing process.
• Manage the implementation and validation of new or modified manufacturing processes and equipment, focusing on IQ/OQ/PQ validation .
• Support material selection and validation for polymers, metals, adhesives, and other materials used in medical devices .
• Create and maintain BOMs , Routers , and DMRs , ensuring that all manufacturing processes meet regulatory requirements and are well-documented.
• Lead efforts to reduce rework , scrap , and labor variance while optimizing manufacturing efficiency.
• Investigate and resolve manufacturing-related problems through the Material Review Board process, ensuring high product quality and compliance.
• Identify and implement innovative manufacturing technologies and best practices to improve processes and product quality.
• Serve as a technical expert, providing manufacturing engineering knowledge to resolve issues and improve existing products and processes.
• Represent the Manufacturing Engineering group on key projects and drive continuous improvement across all manufacturing operations.

Desired Qualifications:

• Bachelor’s degree in Mechanical , Manufacturing , Materials , or Biomedical Engineering (or equivalent).
• Minimum of 6 years of engineering experience, with at least 3 years in the medical device industry .
• Strong knowledge of GMPs , ISO 13485 , and manufacturing process validation (IQ, OQ, PQ).
• Experience with metal processing (machining, polishing, welding), plastics processing , and mechanical assembly .
• Knowledge of Six Sigma , Lean Manufacturing , and Continuous Improvement methods.
• Expertise in machine/tool design and equipment startup (preferred).
• Experience in a cleanroom environment is a plus.
• Ability to analyze and troubleshoot manufacturing processes, improving equipment uptime , yield , and quality .
• Experience with financial analysis related to project cost assessments and capital purchases.
• Strong communication , teamwork , and cross-functional collaboration skills.
• Familiarity with Agile and Oracle systems is a plus.
• Ability to travel up to 10% domestically .

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