Demo

Manager, New Product Introduction

DIALITY INC
Irvine, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/16/2025

Job Description

Job Description

Company & Job Overview :

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, hemodialysis machine that will enable patients to self-treat at home. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The New Product Introduction Manager will oversee the design transfer of new products into manufacturing including support of design for manufacturing and testing. The role involves performing technical planning, managing project risks, verification and validation, cost and risk analysis, leading test and calibration activities and ensuring the design and processes are suitable for mass production. Collaboration with program management, systems, software, mechanical, and electrical engineering teams will be necessary to ensure a robust manufacturable product. This role will work closely and build strong relationships with critical vendors.

Responsibilities :

  • Lead a cross functional team of engineers and technicians to support new production introductions (NPI), process and test development, and continuous improvement initiatives.
  • Build and mentor a high-performing team of engineers, providing leadership, guidance, and professional development opportunities.
  • Work closely with Engineering, Quality, and Regulatory Affairs teams to ensure design for manufacturability, testability and serviceability
  • Manage external contract manufacturing vendors to provide seamless transition from product development to full-scale production.
  • Establish Key Performance Indicators (KPI) to monitor and report on manufacturing performance and process improvements.
  • Allocate resources and manage the team’s workload to ensure timely completion of projects always based on priority.
  • Promote a culture of ownership, collaboration, and accountability within the team.
  • Develops and manages operational initiatives to deliver tactical results.
  • Interacts frequently with leaders, vendors, and other key stake holders.
  • Facilitates communication and presents results and recommendations across cross functional teams.
  • Actively identify and mitigate risks through the NPI process.
  • Ensure the manufacturing processes meet best in class standards.
  • Continuously improve NPI and manufacturing processes for efficiency and effectiveness to meet cost targets

Qualifications & Requirements :

  • B.S. in Engineering
  • 12 years’ progressive engineering experience
  • 3 years of experience formally leading engineering teams / and or organizations
  • Experience in complex fluidic and electro-mechanical medical devices
  • Strong understanding of DFX, GMP, FDA and ISO13485 compliance.
  • Strong computer skills, including Microsoft Office and databases.
  • Proficient in analytical skills, using tools to perform simulations.
  • Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors.
  • Product development lifecycle and manufacturing capabilities knowledge is required
  • Self-motivated and works well under pressure with changing priorities and technical challenges
  • Proven leadership abilities to guide and motivate teams
  • Excellent communication, documentation and reporting skills
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