Sr. Supplier Engineer

2 days ago

San Jose CA United States Noah Medical Full time

About The Team:

The Supplier Engineer will lead the Supplier Component Qualification Process during Noah’s NPI commercialization phase through to sustaining. The role will be responsible for the identification of components and/or assemblies that would require Component Qualification Process, supplier manufacturing process, and all component technical aspects included but not limited to capacity increases, tooling and equipment, part and sub-assembly supplier evaluations, and supplier management during quality and capacity challenges.

The role will collaborate closely with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, meet customer demands, improve processes, support NPI, scale production, improve the factory, own safety and facilities, while maintaining high-quality standards.

A Day In The Life Of Our Sr. Supplier Engineer:

  • Create the component qualification process plan (CQP) and release the report.
  • Train suppliers as needed to meet the requirements of the defined component, assembly, and/or special process CQP.
  • Drive supplier qualification requirements and complete project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Cp/CpK, SPC, Gage R&R, and Process Capability Analysis.
  • Ensure requirements are met by the supplier per required timeline.
  • Review supplier documents and ensure all defined supplier CQP requirements are met.
  • Coordinate completion and approval of Supplier Profile Form.
  • Maintain supplier performance data with Quality Engineer for ongoing supplier evaluation, as required.
  • Initiate suppliers’ visits and evaluations, providing recommendations to the team.
  • Lead supplier changes (for mechanical parts/assemblies) including manufacturing process changes, material changes, production optimization, facility changes, new equipment qualification, and new line validations.
  • Select the right process and supplier for the part, considering long-term fit and total cost of ownership.
  • Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
  • Assess and qualify alternate raw materials or alternate suppliers to overcome supply chain shortages for continued or uninterrupted supply of mechanical parts/sub-assemblies by understanding the impact on overall product design and/or process.
  • Drive suppliers to continually improve their manufacturing process performance to meet Noah Medical for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC, and negotiation.
  • Lead and represent Noah Medical without managerial guidance at multiple suppliers simultaneously.
  • Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
  • Effectively prioritize and advance multiple concurrent projects and tasks.
  • Research and recommend new technologies to improve reliability, efficiency, and contribute to cost reduction.
  • Responsible for the commodity group with the Supplier Engineering team.
  • Be the SME (subject matter expert) of the given commodity.

About You:

  • Education: BS in Mechanical Engineering or equivalent with a minimum of 7+ years’ experience in manufacturing, including 5+ years of supplier engineering or related experience.
  • Prior manufacturing experience in a medical device company, preferably in surgical robotics or equivalent highly complex medical devices.
  • Strong verbal and written skills with the ability to communicate effectively across functions and levels in the organization.
  • Excellent people and project management skills.
  • Experience in MRP systems, MS Office, and related office automation systems.
  • Experience in Medical Device Design Control processes preferred.
  • Experience with sterilization processes preferred.
  • Experience in leading highly technical projects in a cross-functional environment both internally and with CMs/Suppliers.
  • Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
  • Extensive experience with root cause analysis and problem-solving for both technical and process issues.
  • Basic working knowledge of CAD (SolidWorks or other) software.
  • Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
  • Ability to interpret and understand the impact of purchased part changes like alternate raw material change, supplier process change, supplier tooling change.
  • Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001, including experience in auditing suppliers to these standards.
  • Ability to travel to suppliers on an as-needed basis – domestic and international.

Workplace Type: Onsite

Benefits & Perks (For Full-Time Employees):

  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental, and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend
  • Learning & Development Opportunities: On-demand online training and book reimbursement
  • Team building and company organized social and celebration events

#LI-Onsite

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