Supplier Engineer I

Noah Medical San Jose , CA 95111

Posted 2 weeks ago

About The Team:

As the Supplier Engineer I, you will assist with the Supplier Component Qualification Process during Noah's NPI commercialization phase through to sustaining. The role will be responsible for collaboration with 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 work closely with Supplier Engineering 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 Supplier Engineer I:

  • Monitor the component qualification process plan (CQP) and ensure the documents are in PLM (Minerva, Arena, Propel) for cross functional review and approval.

  • Ensures requirements are met by the supplier per required timeline and reviewed with Supplier Engineering.

  • Reviews supplier documents and ensures all defined supplier CQP requirements are met.

  • Coordinate completion and approval of Supplier Profile Form

  • Maintain supplier performance data with Supplier Engineering for ongoing supplier evaluation, as required.

  • Coordinate supplier changes (for mechanical parts/assemblies) including manufacturing process changes, material changes, production optimization, facility changes, new equipment qualification, and new line validations.

  • Assist the Supplier Engineering with assessing and qualifying 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 to overall product design and/or process.

  • Work with Supplier Engineering to continually improve suppliers 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.

  • Assist in developing 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.

  • Assist in the research and recommend new technologies to improve reliability, efficiency and contribute to cost reduction.

  • Work with Supplier Engineering for the commodity grouping and categorization

About You:

  • Education: BS in Mechanical Engineering or equivalent with a minimum of 2 years' experience in manufacturing.

  • Prior manufacturing experience in a medical device company, preferably in surgical robotics or equivalent highly complex medical devices.

  • Good communication, verbal and written, skills with the ability to communicate effectively across functions and levels in the organization.

  • Project management skills

  • Knowledge of MRP systems, MS office and related office automation systems.

  • Knowledge of sterilization processes preferred.

  • Knowledge of supplier technical, quality, and business capabilities.

  • Knowledge of root cause analysis and problem solving for both technical and process issues.

  • Basic working knowledge of CAD (SolidWorks or other) software.

  • Can read and interpret detailed mechanical drawings (GD&T).

  • Can interpret and understand the impact of purchased part changes like alternate raw material change, supplier process change, supplier tooling change,

  • Knowledge of design control and cGMP requirements for medical device

manufacturing per FDA QSR and ISO13485 or ISO9001 and including experience in auditing suppliers to these standards.

  • Can travel to suppliers on a as needed basis.

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

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