Noah Medical
Senior Supplier Engineer
Noah Medical, San Jose, California, United States, 95199
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 Supplier Engineer:Create the component qualification process plan (CQP) and release the report.
Trains supplier 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.
Ensures requirements are met by the supplier per required timeline.Reviews supplier documents and ensures all defined supplier CQP requirements are met.Coordinate completion and approval of Supplier Profile FormMaintain supplier performance data with Quality Engineer for ongoing supplier evaluation, as required.Initiate suppliers’ visit and evaluation 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 to 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 5+ years’ experience in manufacturing, including 7+ 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 skill with the ability to communicate effectively across functions and levels in the organization.Excellent people and project management skillsExperience 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 and including experience in auditing suppliers to these standards.Ability to travel to suppliers on an as needed basis – domestic and international.Workplace Type:
OnsiteBenefits & Perks (For Full Time Employees):Competitive SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, 15-20 days of PTO + use-what-you-need sick daysPaid parental leaveIn-office snacks and beveragesIn-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam building and company organized social and celebration events#LI-Onsite
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Trains supplier 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.
Ensures requirements are met by the supplier per required timeline.Reviews supplier documents and ensures all defined supplier CQP requirements are met.Coordinate completion and approval of Supplier Profile FormMaintain supplier performance data with Quality Engineer for ongoing supplier evaluation, as required.Initiate suppliers’ visit and evaluation 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 to 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 5+ years’ experience in manufacturing, including 7+ 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 skill with the ability to communicate effectively across functions and levels in the organization.Excellent people and project management skillsExperience 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 and including experience in auditing suppliers to these standards.Ability to travel to suppliers on an as needed basis – domestic and international.Workplace Type:
OnsiteBenefits & Perks (For Full Time Employees):Competitive SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, 15-20 days of PTO + use-what-you-need sick daysPaid parental leaveIn-office snacks and beveragesIn-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam building and company organized social and celebration events#LI-Onsite
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