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Manufacturing Operations Manager
2 months ago
Avive Solutions, Inc. is a leading healthcare technology company that has developed an FDA-approved, next-generation Automated External Defibrillator (AED) and response system to save lives. Our mission is to provide rapid access to life-saving defibrillation for cardiac arrest victims.
Job DescriptionWe are seeking a highly skilled Manufacturing Operations Manager to lead our high-volume production facility in compliance with common good manufacturing practices (CGMPs) and applicable FDA and ISO quality system regulations.
Key Responsibilities:- Process Development: Plan, design, implement, and validate manufacturing processes for production, including hands-on assembly, design, and manufacturing transfer.
- Team Leadership: Lead cross-functional teams to set up and qualify high-volume production facilities, ensuring compliance with CGMPs and quality system regulations.
- Quality Assurance: Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations, authoring test protocols, performing testing, and authoring reports to support test method validation, design verification, design validation, process validation, and intended use validation.
- Process Improvement: Lead process improvement teams to analyze and improve existing processes using Lean Manufacturing principles, coordinating with suppliers and external resources as needed.
- Statistical Analysis: Use Statistical Process Control concepts and Minitab Statistical Analysis software to analyze process data.
- Design and Development: Generate detailed fabrication drawings using SolidWorks, with familiarity of GD&T and tolerance stack-up analysis.
- Packaging and Validation: Lead packaging design, configuration design, and packaging validation testing to ensure safe packaging.
- Training and Development: Provide mentoring and training to Manufacturing Engineering Technicians and Manufacturing Engineering Assistants in subjects such as equipment maintenance and repair, machine programming and optimization, and other areas of responsibility.
- Education: Master's degree in Manufacturing Engineering, Mechanical Engineering, or closely related field.
- Experience: One year of experience in manufacturing engineering, with expertise in manufacturing technologies, automation, plant layout, and material handling.
- Skills: Lean Manufacturing principles, Six Sigma problem-solving, quality control, statistical process control, and FDA 21 CFR Part 820 and ISO 13485 quality system regulations.
- Competitive Salary: $120,000-$160,000 annually, depending on experience.
- Telecommuting Options: Available for this position.
Avive Solutions, Inc. is an equal employment opportunity employer and welcomes applications from diverse candidates. We provide reasonable accommodations for qualified individuals with disabilities.