New Product Introduction Manager for Medical Devices

Job Overview

We are in search of a dedicated and skilled Manager of New Product Introduction (NPI) to spearhead the transition of new products into manufacturing. This pivotal role entails overseeing the vital elements of product development, spanning from design and testing through to mass production, while ensuring all operations are efficient, compliant, and scalable. You will engage with cross-functional teams and external collaborators to launch innovative medical devices, thereby positively impacting the lives of patients reliant on these advancements.

Key Responsibilities

• Lead and nurture a cross-functional team of engineers and technicians, facilitating the introduction of new products, process advancements, and continuous improvements.
• Cultivate a high-performance atmosphere by providing leadership, mentoring, and opportunities for professional growth.
• Collaborate closely with Engineering, Quality, and Regulatory Affairs teams to ensure products are designed for optimal manufacturability, testability, and serviceability.
• Manage relationships with external contract manufacturing partners, ensuring seamless transitions from development to full-scale production.
• Define and monitor Key Performance Indicators (KPIs) to evaluate and enhance manufacturing performance and operational efficiency.
• Allocate resources effectively and manage team workloads to ensure timely project completion aligned with priority objectives.
• Promote a culture of ownership, collaboration, and accountability within the team.
• Drive operational initiatives to achieve tactical outcomes and meet business objectives.
• Serve as a liaison, engaging regularly with leaders, vendors, and other key stakeholders.
• Facilitate effective communication and provide updates and recommendations across teams.
• Identify and mitigate risks throughout the NPI process to ensure successful product launches.
• Ensure that manufacturing processes adhere to the highest standards of quality and compliance.
• Continuously evaluate and enhance NPI and manufacturing processes to meet cost and efficiency targets.
  
  

Required Skills

• Extensive experience leading engineering teams, with strong leadership capabilities that inspire and motivate.
• Excellent analytical skills, with a background in conducting simulations and data analysis.
• Comprehensive knowledge of Design for Excellence (DFX), Good Manufacturing Practices (GMP), FDA regulations, and ISO 13485 compliance.
• Proficiency in Microsoft Office and database management tools.
• Proven capability to navigate complex issues with competing factors requiring meticulous analysis.
• Familiarity with the product development lifecycle and manufacturing processes.
• Ability to effectively manage competing priorities, work under pressure, and adapt to shifting technical challenges.
  
  

Qualifications

• Bachelor's degree in Engineering or a related discipline.
• A minimum of 12 years of progressive engineering experience, including at least 3 years in leadership roles.
• Experience with complex fluidic and electro-mechanical medical devices.
  
  

Career Growth Opportunities

This position offers the potential for significant professional development, with opportunities to lead, mentor, and continuously improve processes, aligning with the company’s commitment to fostering growth.

Company Culture And Values

Our organization values a high-performance environment that emphasizes leadership, collaboration, and accountability, encouraging team members to take ownership of their work and engage in professional development.

Employment Type: Full-Time