Jobs · Quality Assurance · California

Director, NPI, Sustaining & TT Eng

Cytek Biosciences · Fremont, CA · 1 wk ago
Quality AssuranceFull-time

Essential Duties And Responsibilities

  • Lead multinational engineering teams to ensure end-to-end successful launch of new products, from R&D hardware assistance to full commercialization and field service.
  • Assist R&D to bring complex new products to manufacturing and service readiness through product optimization and process development.
  • Product Lifecycle Management - Ensures smooth transition from new product introduction (NPI) to sustaining phase.
  • Support R&D on hardware project requests.
  • Maintain product performance, reliability, and compliance throughout its lifecycle.
  • Manage end-of-life (EOL) planning and execution.
  • Issue Resolution & Root Cause Analysis - Lead cross-functional teams to resolve field issues, quality problems, and customer complaints.
  • Drive root cause analysis and corrective actions for product failures or defects, leading to DOA (death on arrival), Failure at Installation, failure during warranty period, and failures during service period.
  • Implement preventive measures to avoid recurrence, proactively identify other areas where lessons learned and solutions created can be applicable before a failure is experienced.
  • Cost Reduction & Value Engineering - Identify opportunities for cost optimization without compromising quality or compliance.
  • Support design changes for manufacturability, serviceability, and supply chain efficiency.
  • Support and deliver cost savings associated with the Value Engineering category, built into the operating budget.
  • Regulatory & Quality Compliance - Ensure all sustaining activities meet regulatory requirements (FDA, ISO, CE, etc.). Maintain documentation and change control processes for audits and inspections.
  • Supplier & Component Management – OEM Development - Manage component obsolescence and alternative sourcing to improve Supply Chain robustness and reliability.
  • Collaborate with suppliers and supply chain teams for quality improvements and continuity of supply.
  • Close collaboration with the Strategic Sourcing team to develop second and third sources for all A and B parts (plus major C parts).
  • Identify opportunities for OEM products that can be offered to enhance/supplement/complement Cytek offerings (collaboration with Marketing and Platform teams), develop a partnership in collaboration with Supply Chain, Strategic Sourcing, and Legal teams (if and as needed).
  • Engineering Change Management & Tech Transfers - Oversee Engineering Change Orders (ECOs) and ensure timely implementation.
  • Validate changes through risk assessments and testing.
  • Manage Tech Transfer projects from concept to planning to full execution.
  • Tech transfers can be between Global Cytek sites and/or from Acquired entities to any of the Global Cytek facilities.
  • Customer & Field Support - Provide technical support for service teams and customers.
  • Analyze field data to identify trends and drive product improvements.
  • Cross-Functional Collaboration - Develop strong partnerships with relevant companies and stakeholders to ensure fulfillment of the company's needs.
  • Create/reinforce interdisciplinary connections between technical leads and managers cross-functionally with R&D organization, software, supply chain, manufacturing, finance, quality, product platforms, service, field applications, and other teams/functions in Cytek.
  • Work closely with Quality, Regulatory, Manufacturing, and R&D teams.
  • Act as the technical authority for sustaining products.
  • Continuous Improvement - Implement Lean and Six Sigma methodologies for process and product improvements.
  • Drive initiatives to enhance reliability, drive DOA (death on arrival), and warranty costs to zero occurrence levels.
  • Leadership & Project Management & Team Development - Build and mentor high-performing products, sustaining, new product introduction, and tech transfer disciplines/sections, and engineering teams.
  • Set priorities, define budget, resources, and schedules, manage resources effectively and efficiently to ensure deliverables are met on schedule and within budget.
  • Define budget, resources and schedule for each project/program implementation and provide concise status updates.
  • Improve engineering organization capabilities through formal training programs on engineering disciplines including ESDA (Engineering Statistics and Data Analysis).
  • Lead the team to ensure that career paths are outlined and skills are enhanced.
  • Perform other duties as assigned

Requirements & Qualifications

  • Bachelor’s with 10+ years of hands-on experience at market-relevant organizations in new product introduction, sustaining for commercialized products, technical transfer of complex instrumentation/hardware, and project management in both large and small-to-medium medical device, life science, and/or telecommunication organizations.
  • PhD degree in at least one relevant engineering discipline or equivalent experience preferred.
  • Thorough understanding of product development, product sustaining, and NPI process.
  • Extensive hands-on experience in managing multi-national engineering organizations.
  • Proven experience in bringing a product to market and ability to collaborate with Platform, Marketing, and Sales teams to do so.
  • Proven experience in building strong teams that meet high-performance standards and goals across multiple disciplines.
  • Strong interdisciplinary leadership experience in electrical, mechanical, regulatory, prototyping, validation, and test areas.
  • Able to implement an engineering strategy for a major business unit that balances operations and support requirements with engineering development programs.
  • Passion for leading, mentoring, and inspiring strong, talented engineers as a co-worker, actively involved in day-to-day engineering.
  • Ability to identify and recruit top talent.
  • Curious about our business, confident, and responsive working with executives.
  • Experience leading top-performing, diverse, global teams, preferred.
  • Highly collaborative, inclusive, creative, and flexible.
  • Experience defining KPIs and OPIs, managing performance through metrics.
  • Ability and willingness to travel globally as necessary (when safe and permitted).

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