Vice President of Manufacturing-CA FC06-3349

2 months ago

California, United States Global Recruiters of West Palm Beach Full time

Required Experience: 15 years of progressive experience in Operations Management within the medical device industry, demonstrating a successful track record in managing complex manufacturing operations. Required Education: Minimum of a bachelor’s degree in engineering, Operations Management, or a related field. A master’s degree or equivalent is highly desired

Job Description

Our client is an emerging diabetes company with a late stage development medical technology seeking a Vice President of Manufacturing for its CA location. As the Vice President of Manufacturing, the incumbent holds the pivotal responsibility of steering all aspects of manufacturing operations. This vital role encompasses supervising the entire production process and fostering collaborative efforts across various departments, including Engineering, Quality, and Finance. The aim is to guarantee that products not only meet stringent Quality standards but are also delivered within the set timelines. A key aspect of this position involves driving efficiencies and enhancing the scalability of the manufacturing processes, ensuring that operations are both effective and adaptable to changing demands.

Key Duties, Activities and Responsibilities:

• Lead and innovate in the manufacturing operations of high-volume, complex medical devices, ensuring scalability and efficiency. • Implement World Class Manufacturing practices to enhance productivity and product quality. Oversee global manufacturing facilities, aligning operations with corporate goals and market demands. Ensure strict adherence to the Quality System and Device Master Record, maintaining the highest standards of quality and safety. • Drive innovation in manufacturing processes and closely collaborate with R&D to bring new technologies to market. • Drive continuous improvement initiatives and Cost of Goods Sold (COGS) reduction strategies, optimizing operational costs. • Develop and maintain manufacturing capacities and robust disaster recovery plans, ensuring uninterrupted operations. • Develop and execute supply chain management strategies to ensure on-time delivery of parts with highest quality and lowest cost. • Establish solid working relationships at a senior level with our internal customers &strategic supplier base in support of our on-going business requirements. • Manage inventory levels to meet Company's inventory turns target while achieving on-time shipment targets. • Collaborate with Engineering, Quality, and Finance departments for operational synergy. • Manage multiple projects, seamlessly transitioning new products into manufacturing while maintaining yield targets. • Uphold compliance with FDA regulations and ISO standards, with emphasis on advanced medical device manufacturing and current good manufacturing practices (CGMP). • Engage with key external stakeholders, including suppliers and regulatory bodies, to foster strong, productive relationships. • Effectively manage the department budget and personnel, fostering a culture of excellence and continuous learning Knowledge & Skills

Work Experience, Skills and Education Required:

Minimum Qualifications and Experience: • Educational Background: Minimum of a bachelor’s degree in engineering, Operations Management, or a related field. A master’s degree or equivalent is highly desired. • Professional Expertise: At least 15 years of progressive experience in Operations Management within the medical device industry, demonstrating a successful track record in managing complex manufacturing operations. • Industry Knowledge: Extensive knowledge of Current Good Manufacturing Practices (CGMP), ISO 9001 and ISO 13485 standards, European Medical Device Directives (MDD), Canadian Medical Device Regulations (CDMR), and Japanese Regulations (J-GMP). Familiarity with strategic planning methodologies and advanced problem-solving skills. • Regulatory Acumen: Proficient understanding of FDA regulations and other global regulatory requirements relevant to medical device manufacturing. • Leadership Skills: Strong leadership qualities with a proven ability to inspire, manage, and develop a high-performing manufacturing team. Experience in change management and organizational development. • Communication and Collaboration: Excellent communication skills, both verbal and written, with the ability to effectively interface with cross-functional teams and senior management. • Analytical and Strategic Thinking: Highly analytical mindset with a strategic approach to problem-solving, able to anticipate industry trends and adjust strategies accordingly. • Project Management: Demonstrated experience in managing large-scale projects, including new product introductions and process improvements, from inception to completion. • Innovative Mindset: A forward-thinking approach, constantly seeking innovative solutions to enhance manufacturing processes and product quality, and reduce product cost. • Adaptability: Ability to thrive in a dynamic, fast-paced environment, adapting to evolving industry challenges while maintaining operational excellence.

Preferred Qualifications: • Medical Device Background: Demonstrated experience in successfully implementing manufacturing processes for Class II/Class III devices. • Advanced Technical Expertise: Specialized knowledge in Manufacturing Process Engineering, showcasing proficiency in the latest manufacturing technologies and techniques to handle volatile chemicals and biological products. • Project Management Excellence: Strong background in Project Management, especially in the context of medical device industry, with a focus on efficiency, timelines, and budget management. • Experience with New Product Scale-Up: Proven track record in successfully starting up and scaling up new product introductions, particularly in high-tech or specialized medical device sectors. • Continuous Improvement Focus: A passion for continuous improvement and lean manufacturing principles, with tangible results in previous roles. • Cross-Functional Leadership: Experience in leading cross-functional teams, fostering collaboration and innovation across departments. • Global Operations Insight: Experience in managing or collaborating with international manufacturing facilities, demonstrating a global perspective in operations. • Data-Driven Decision Making: Proficiency in utilizing data analytics and metrics to guide decision-making processes and improve operational outcomes. • Technology Adoption: Aptitude for embracing and integrating new technologies to enhance manufacturing capabilities and product innovation. • Environmental and Safety Compliance: Commitment to environmental sustainability and maintaining the highest standards of workplace safety. GRN West Palm Beach

9897 Lake Worth Road, Suite 202 Lake Worth, FL 33467 USA

#J-18808-Ljbffr

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