Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.
Job Description
Primary Function of Position:
Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Monitors and works with suppliers to improve supplier performance in NPI product and process development. Leads and executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.
This role will focus on manufacturing of mechanical components including external enclosures, functional opto-mechanical components, sub-assemblies, and fully finished systems for some of Intuitive’s newest vision products. The ideal candidate has experience bringing electronic devices to market, preferably medical devices: has worked directly with component suppliers and has demonstrated knowledge in a variety of electronics and enclosure manufacturing technologies such as metals tooling and machining, plastics molding or processing, as well as coating and finishing applications. The ideal candidate also has experience in process and metrology validation, specifically on measurement correlation and data analysis for process capability based on supplier-provided test and measurement data.
Roles and Responsibilities:
- Work with suppliers and ISI engineering and sourcing teams during the New Product Introduction phase, including but not limited to the below deliverables:
- Complete project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
- Collaborate with Design and Sourcing teams to define the right process and supplier for the part, considering long-term fit and total cost of ownership.
- Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
- Drive DFM and process assessments by engaging suppliers early in development cycle to feedback on manufacturability improvements during the design phase.
- Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
- Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
- Lead and drive to closure supplier variance mitigations from symptom through root cause analysis to corrective action, including thorough CAPA documentation. Execute corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis.
- Lead and envision supplier development and improvement initiatives across multiple suppliers simultaneously and with little to no managerial guidance:
- Build, own, and relentlessly pursue a vision for developing suppliers with a focus on excellence in all KPIs including Supplier Owned Quality, Capacity, and Sub-tier Management.
- Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
- Clearly communicate project status, supply health, and supplier recommendations to key stakeholders and leaderships with little to no guidance.
- Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
- Effectively prioritize and advance multiple concurrent projects and tasks, with delegation and peer task management as needed.
- Review, analyze and close internal and external customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications.
Qualifications
Required Knowledge, Skills, and Experience:
- Minimum 8 years related experience with an B.Sc. or B.Eng Engineering degree or 6 years’ experience with M.Sc. or M.Eng in Engineering, or 3 years’ experience with PhD or Dr.-Ing equivalent level.
- 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 in a self-driven environment.
- Excellent analytical and problem-solving skills along with good judgment and solid demonstration of engineering first principles, Design of Experiments, and Root Cause Analysis methodologies with suppliers and cross-functional stakeholders as part of problem-solving process.
- 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).
Required Education and Training:
- Minimum Education: B.Sc. degree in Engineering, advanced degree preferred.
- Experience with statistical analysis software such as Minitab or JMP.
- Ability to read and interpret detailed mechanical drawings (GD&T) using ASME Y14.5-2018 (R2024) and relevant ISO dimensioning and tolerancing standards.
Working Conditions
- Ability to travel to suppliers on an as-needed basis within EU or internationally.
Preferred Skills and Experience
- CAD experience with 3D modeling tools such as PTC Creo and SolidWorks.
- Experience in a high-volume medical device company and associated regulatory framework and procedures.
Additional Information
Wir schätzen jede Person in ihrer Individualität – unabhängig von Geschlecht, ethnischer oder sozialer Herkunft, Religion, besonderen Bedürfnissen, Alter oder sexueller Identität. Diskriminierung hat bei uns keinen Platz.
Haftungsausschluss für US-Exportkontrollen: In Übereinstimmung mit den U.S. Export Administration Regulations (15 CFR §743.13(b)) können einige Positionen bei Intuitive Surgical US-Exportkontrollen für potenzielle Mitarbeitende unterliegen, die Staatsangehörige von Ländern sind, die derzeit einen Embargo- oder Sanktionsstatus haben.
Bestimmte Informationen, die Sie im Rahmen der Bewerbung angeben, werden verwendet, um festzustellen, ob Intuitive Surgical (i) in Ihrem Namen eine Exportlizenz von der US-Regierung einholen muss (das Lizenzierungsverfahren der Regierung kann bis zu sechs Monate dauern) oder (ii) einen Technology Control Plan (TCP) implementieren muss (verlängert den Einstellungsprozess in der Regel um 2 Wochen).
Für alle Positionen bei Intuitive, die Exportkontrollen unterliegen, steht ein endgültiges Angebot unter dem Vorbehalt, dass vor dem geplanten Eintrittsdatum eine genehmigte Exportlizenz und/oder ein vollständig ausgeführter Technology Control Plan (TCP) vorliegt. Das Eintrittsdatum kann dabei angepasst werden, sofern der Genehmigungsprozess den Einstellungsbedarf nicht unangemessen beeinträchtigt.
Diese Position kann abhängig von den betrieblichen Anforderungen und/oder der Erfahrung der ausgewählten Kandidatin bzw. des ausgewählten Kandidaten auf einer anderen Jobstufe als hier angegeben besetzt werden. Die Vergütung richtet sich nach der Jobstufe sowie der Qualifikationen der Kandidatin bzw. des Kandidaten, selbstverständlich unter Berücksichtigung aller gesetzlichen Vorgaben.
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