Intuitive
Healthcare
SeniorSupplierEngineer
“Senior Supplier Engineer at Intuitive. Skills: Purchased part qualification and improvement, Supplier regulatory, environmental, and compliance execution, Supplier quality and corrective action leadership. On-going sustaining and improvement efforts for purchased parts with a focus on packaging and labeling. Support supplier regulatory, environmental, and compliance execution for the Endoluminal business unit”
What You'll Achieve.
Improvement efforts for purchased parts; Ensure suppliers and parts meet global requirements for qualification, release, and sustained production; Reduce risk, lower cost, or meet new regulatory requirements; Support global expansion; Timely and accurate supplier submissions for part qualification; Improve Supplier Engineering processes and procedures; Strengthen problem-solving rigor and consistency; Ensure suppliers have appropriate PMC, spares and track when replacement parts or firmware updates are needed
Industry & Context.
Excellent analytical, problem-solving, and engineering judgment skills; Strengthen problem-solving rigor and consistency
Proof of vaccination against certain diseases including COVID-19 may be required, May be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status
What They're Looking For.
Must Have
BS degree in Engineering or equivalent, Minimum 8 years related experience in Supplier Quality Engineering and/or Supplier Development or related field, Demonstrated ability to partner effectively with Quality, Regulatory, Environmental, and Compliance organizations to develop new QMS procedures that can scale, working knowledge of global regulatory and environmental compliance requirements impacting supplied parts and assemblies, Experience with packaging materials and regulations such as thermoforming trays, pouches, cartons, adhesives UDI, country-specific labeling, and UL requirements as needed, Demonstrated experience in SCARs and CAPAs using excellent analytical, problem-solving, and engineering judgment skills, written and verbal communication skills, including presentations to senior and executive leadership, Working knowledge of 21 CFR Part 820 and ISO 13485, including supplier auditing experience, Proficiency with common business tools and ERP systems (SAP preferred), Ability to read and interpret mechanical drawings and technical specifications
Nice to Have
Knowledgeable how global regulations impact parts and finished goods manufactured by contract manufacturers for US, APAC, EMEA, EU, Experience with environmental compliance frameworks including REACH, MDR, Conflict Minerals, Prop 65, Packaging, and Battery regulations, Familiarity with global trade, import/export requirements, and UL standards, Familiarity with packaging requirements such as 21 CFR 820 (especially labeling, packaging, purchasing controls), EU MDR labeling & packaging expectations, UDI / GUDID requirements and traceability expectations
What You'll Do.
On-going sustaining and improvement efforts for purchased parts with a focus on packaging and labeling
Support supplier regulatory
and compliance execution for the Endoluminal business unit
Ensure suppliers and parts meet global requirements for qualification
and sustained production
Provide supplier DFM feedback on specifications with a focus on packaging materials and designs
Own purchased part qualification activities for packaging and labeling commodities
Resolve supplier quality issues and implement improvements to performance
Manage project plans and timelines
Participate in packaging commodity reviews and supplier business reviews
Understand in-country regulatory
and trade compliance requirements for each part in the BOM
Own supplier deliverables and obtain supplier documentation required to meet in-country regulatory
and trade compliance requirements
Act as the escalation point for unresolved supplier compliance documentation
Partner cross-functionally to shape and improve Supplier Engineering processes and procedures related to material regulation
Serve as the Endoluminal Supplier Engineering representative to Intuitive corporate CAPA teams for escalated or cross-BU quality issues
Instruct SCAR training and other training for the Endoluminal Supplier Engineering team
Develop a master database for Intuitive owned equipment located at suppliers
Ensure suppliers have appropriate PMC
spares and track when replacement parts or firmware updates are needed
How You'll Work.
Team & Collaboration
Partner effectively with Quality, Regulatory, Environmental, and Compliance organizations; Work closely with product design, manufacturing, and project teams; Partner cross-functionally to shape and improve Supplier Engineering processes and procedures; Serve as the Endoluminal Supplier Engineering representative to Intuitive corporate CAPA teams
Communication Scope
Written and verbal communication skills; Presentations to senior and executive leadership
Process & Methodology
Manage project plans and timelines
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