Senior Supplier Quality Engineer

6 days ago

Sunnyvale CA, United States Intuitive Full time
Job Summary:

As a Senior Supplier Quality Engineer at Intuitive, you will play a critical role in ensuring that our suppliers meet the highest standards of quality, service, delivery, and cost. You will be responsible for driving suppliers to continuously improve their business and manufacturing processes, evaluating and selecting suppliers, and guiding engineering in choosing suppliers for new products. Your expertise in metal injection molding, metal machining, and/or plastic injection molding will be invaluable in this role.

Key Responsibilities:
  • Develop and implement supplier quality improvement plans to ensure compliance with ISI requirements.
  • Conduct supplier audits and assessments to evaluate their quality, service, delivery, and cost performance.
  • Collaborate with suppliers to identify and implement process improvements and cost reductions.
  • Manage supplier changes, including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
  • Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
  • Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation.
  • Prioritize and advance multiple concurrent projects and tasks, clearly communicating project status to key stakeholders.
  • Build, own, and relentlessly pursue a vision for developing suppliers.
  • Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics.
  • Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive's requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC, and negotiation.
  • Implement corrective and preventive actions for supplier process by driving supplier's investigations and root cause analysis.
  • Provide effective and timely supply base health information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance.
  • Prepare and deliver supplier communications as required by unsupervised working with suppliers on scorecard creation.
  • Work with suppliers and ISI engineering for the new product introduction to create product supplier landscapes to establish launch readiness and report to management, develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability, and DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
  • Influence and guide Engineering in choosing suppliers by establishing selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
  • Review, examine, and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications.
  • Evaluate corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence.

Requirements:
  • Minimum Education: BS degree in Mechanical or Biomedical Engineering or equivalent experience, advanced degree preferred.
  • Minimum 6 years related experience in engineering and manufacturing of metal injection molding (MIM), machined metal or plastic injection molding parts. Metal injection molding experience is highly desirable.
  • Excellent written and verbal communication skills including presentations to executive level management.
  • Excellent Interpersonal skills and team building skills.
  • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
  • Excellent Project Management skills.
  • Excellent analytical and problem-solving skills along with good judgment.
  • Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
  • Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing).
  • Excellent knowledge of 21 CFR part 820 and ISO 13485.
  • Significant computer experience using Windows, Word, Excel, Project, Access, and ERP Information Systems, preferably SAP or Agile.
  • CAD experience with 3D modeling tools is a plus.
  • Experience with statistical analysis software such as Minitab is a plus.
  • Proven ability to motivate suppliers.
  • Experience in a high-volume medical device company is a plus.
  • Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
  • Ability to travel to suppliers on an as needed basis - domestic and international (approx 25%).

Additional Information:
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. EEO and AA Policy We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed. Intuitive

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