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Manufacturing Operations Manager
2 months ago
Avive Solutions, Inc. is a pioneering healthcare technology company that has developed a groundbreaking Automated External Defibrillator (AED) and response system to revolutionize cardiac arrest response. We are seeking a highly skilled Manufacturing Operations Manager to lead our manufacturing efforts and drive process excellence.
Key Responsibilities:- Develop and implement manufacturing processes and procedures to ensure high-quality products.
- Lead cross-functional teams to set up and qualify high-volume production facilities, ensuring compliance with FDA and ISO quality system regulations.
- Collaborate with suppliers and external resources to develop and implement process improvement plans.
- Author test protocols, perform testing, and author reports to support test method validation, design verification, and process validation.
- Develop and manage KPIs for the manufacturing process across all production lines.
- Master's degree in Manufacturing Engineering, Mechanical Engineering, or a closely related field.
- At least one year of experience in manufacturing engineering, with expertise in manufacturing technologies, automation, and quality control.
- Strong knowledge of FDA 21 CFR Part 820 and ISO 13485 quality system regulations.
- Excellent leadership and communication skills.
- Competitive salary range: $120,000-$160,000* Annually
- Opportunities for professional growth and development
- A dynamic and innovative work environment
*Depending on experience
