Sr Staff Engineer, Instrument NPI (New Product Introduction)

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Sr Staff Engineer, Instrument NPI (New Product Introduction)
Position is based in Menlo Park, CA.

PacBio (NASDAQ: PACB) is a premier life science technology company that is designing, developing and manufacturing advanced sequencing solutions to help scientists and clinical research resolve genetically complex problems.  Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health.  We are now entering the century of biology and genomics is at the heart of the next revolution.  Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team.
Pacific Biosciences is looking for an experienced Instrument NPI (New Product Introduction) Sr Staff Engineer to support our new DNA sequencer product development and introduction process. The Staff Engineer will provide hands-on support during technology feasibility evaluations and continues through the release of new products into production. Along the way, the NPI Engineer will partner with the design engineering team to complete product designs, coordinate with on-site manufacturing & manufacturing process technology partners, and orchestrate the build of prototype assemblies. You will be responsible for the creation and release of critical items such as Statement of Work, product BOMs, procedures, work instructions, tooling, and packaging. You will work closely with the manufacturing team to understand and provide what they need to be successful for mass production.

Responsibilities

• Provide manufacturing engineering hands-on support for our new DNA sequencer products, and for process development across in-hose Manufacturing, Contract Manufacturers (CMs) and the overall supply chain partners
• Work with ME/EE Engineering, Quality, Sourcing, Project Managers, and Supply Chain partners & CMs to develop and qualify tools, fixtures, assembly and test equipment, processes and process flow, DFM and DOE proposals
• Identify, develop and qualify manufacturing test fixtures and tools to aid in mass production of products
• Ensure NPI projects meet deadlines, quality, and reliability targets
• Communicate cost and schedule impacts of manufacturing operations
• Actively participate in the product development and design review process to assess for manufacturability
• Drive DFx activities at Suppliers and CM's
• Drive development builds across on-site Manufacturing, Suppliers and CM's
• Create and manage documentation for manufacturing and test processes to meet product and quality standards.
• Ensure a smooth transition from NPI to mass production, manage the flow and implementation of change requests
• Ensure on-site Manufacturing, Suppliers and CM's meet quality and productivity targets at launch
• Drive line failure analysis and solution implementation on-site and at all suppliers and CM's during the NPI phase
• Drive process improvement at all suppliers and CMs with systematic methods – SPC, DOE, etc
• Support cost optimization and yield improvement activities
• Work with Engineering, Sourcing, and Quality teams to qualify new suppliers and CM's
• Work with Engineering, Quality, and Field Service teams to drive field failure analysis and reduce DOA (Dead on Arrival) and ELF (Early Life Failure) during early stages of product rollout
• Understand how to drive yield studies, review FAI/CpK data, develop and qualify CMF (Color, Material and Finish) requirements

Requirements

• 8+ years of in-house and outsourced product introduction in the Medical Devices, Life Sciences lab equipment or Semiconductor capital equipment space
• Strong working knowledge of SolidWorks, CAD
• Experience with hybrid and fully outsourced manufacturing strategies
• Knowledge of PCBA, mechanical, electro-mechanical fabrication, tools, assembly, and test operations
• Minimum 5 years of experience working with Contract Manufacturers
• Knowledge of Statistics, Spreadsheet, PLM and ERP system
• Ability to apply principles of logical thinking to a wide range of intellectual and practical problems
• Experience with strategic projects and analysis
• Ability to work independently and meet tight deadlines
• Hands-on problem solver
• Excellent attention to detail with strong organizational skills
• Familiar with manufacturing processes such as injection molding, CNC (milling, lathing), forming (stamping, forging, die casting, wax-casting), surface finishing and coatings, and assembly
• Good understanding of Mechanical Design, GD&T, Failure Analysis, DOE, SPC and Statistical Analysis, Metrology equipment
• Experience driving product design using Design for Manufacturing (DFM) methods to ensure robust manufacturability, yields, cost reduction and ability to scale
• Good knowledge of designing and reviewing tooling, fixtures, and semi-automated equipment
• BS Degree in ME or equivalent experience
• Office-365 Suite (Excel, Outlook, SharePoint, OneDrive, Teams, MS Project or similar)
• Ability to travel up to 30% between manufacturing sites

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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