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).