Roles and Responsibilities
Drive PCBA manufacturing qualification at contract manufacturers, including readiness requirements and milestone reviews.
Provide PCB/PCBA DFM feedback and escalate manufacturability risks early in product development.
Complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis
Develop and implement manufacturing technologies and process improvements to enhance quality, reliability, throughput, and cost.
Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation
Select the right process and supplier for the part, considering long term fit and total ownership cost
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
Effectively prioritize and advance multiple concurrent projects and tasks
Clearly communicate project status to key stakeholders
Build, own, and relentlessly pursue a vision for developing suppliers
Understand proper level of documentation detail for tracking of actions and justification of decisions
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. Lead these efforts without managerial guidance at several suppliers simultaneously
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 independently working with suppliers on scorecard creation
Work with suppliers and ISI design engineering for the new product introduction to:
Create product supplier landscapes to determine 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.
DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
Influence and guide Design Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers
Review, analyze 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
Skills/Job Requirements
Minimum 3 yrs related experience in engineering/manufacturing of Electronics (PCBA, PCA, cable assemblies, wiring harnesses, etc.) preferred.
Experience with board assembly processes and equipment, including stencil, paste print, SPI, pick and place, SMT reflow, AOI, AXI, selective solder, flying probe, wash, and conformal coating.
PCBA DFM experience
Excellent written and verbal communication skills including presentations to executive level management
Excellent Interpersonal, team building and project management skills
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
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
Required Education and Training
Minimum Education: BS degree in Engineering or equivalent experience, advanced degree preferred
Experience with SMT/PCBA manufacturing and process development
Experience in a high-volume medical device company is a plus
Working Conditions
Ability to travel to suppliers on an as-needed basis – domestic and international.
Preferred Skills and Experience
Medical Device experience is a plus
Supplier management experience is a plus
Advanced degree preferred
DFM tools experience, such as Valor or Allegro, is a plus.
Experience with statistical analysis software such as Minitab is a plus
Experience in a high-volume medical device company is a plus
Intuitive is an Equal Employment Opportunity 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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
