Primary Function of Position
Responsible for ensuring suppliers meet ISI requirements for quality service delivery and cost. Drive both suppliers and internal teams to continuously improve both manufacturing and business processes. Evaluate and select the optimal manufacturing technologies and processes for NPI projects. Guide engineering in the selection and application of processes for new product designs and provide DFM input to ensure robust manufacturability. Support both NPI and ongoing production by monitoring product and process performance and work with design and manufacturing teams to implement improvements. Lead and execute detailed supplier projects to implement changes affecting product quality cost capacity risk mitigation and integration of new manufacturing technologies.
The ideal candidate possesses a broad process experience (conceptual and hands on) in metal machining fiberoptic assemblies and/or plastic Injection molding and has the skills and experience to assess and develop optimal supplier partners in these categories while mentoring others in this skillset.
Roles & Responsibilities:
As an expert in the field use professional concepts in developing resolution to critical issues and broad design matters. Experience leading departmental and cross functional projects and teams. Significant experience turning innovative ideas into real products and solutions.
Complete project/ part qualification deliverables including: Supplier pFMEA Process Validations (IQ/OQ/PQ) Inspection Reports Gage R&R and Process Capability Analysis
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 cost of ownership
Expertly translates complex technical problems into solutions. Integral technical advisor to senior leaders.
Manage complex 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
Works on issues that impact design/selling success or address future concepts products or technologies. Creates formal networks with key decision makers and serves as external spokesperson for the organization.
Own and drive to closure supplier variances from symptom through root cause analysis to corrective action including up to SCAR documentation
Effectively prioritize and advance multiple concurrent high priority projects and tasks
Effectively integrates and distills communications across multiple teams and activities for cohesive and unified messaging within teams and across ISI
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 Intuitives 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 suppliers 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 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 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
Other reasonable duties
Qualifications :
Skills Experience Education & Training:
Minimum Education: MS degree in Mechanical or Biomedical Engineering or equivalent experience
Minimum 12 years related experience in engineering and manufacturing of machined metal or plastic injection molding parts. Complex electrical and fiberoptic cabling manufacturing and 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 sound 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 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.
Mandatory Notices
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 employeeswho 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 governments 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 employeesstart 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.
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 compensation ranges are listed.
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 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.
Mandatory Notices
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 employeeswho 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 governments 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 employeesstart 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.
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 compensation ranges are listed.
Remote Work :
No
Employment Type :
Full-time
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