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
The mission of Supplier Engineering is to develop a world-class supplier network for our products that ensures continuity of supply, scales to meet demand, reduces costs, and anticipates and mitigates supply chain risks. Supplier Engineers collaborate throughout the product development lifecycle, executing strategic projects to optimize commodities, sub-commodities, and individual suppliers. They carry out detailed initiatives with suppliers to implement changes and improvements that impact quality, cost, capacity, risk, and sub-supplier management, as well as to launch new products.
This role specifically focuses on the manufacturing of catheters, vision probes, and needles for medical applications. The ideal candidate should have experience in bringing medical devices to market, preferably in the medical device sector or similar regulated industries.
Essential Job Duties
- 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.
- Work with product development, test engineering, and supplier to design, develop, qualify, and implement functional test processes at supplier.
- Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations
- Collaborate with suppliers and internal stakeholders to determine deliverables and define timelines.
- Complete project deliverables including: Supplier pFMEA, Component Qualification (FAIR), Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
- Lead the team in overcoming difficult process issues.
- Develop suppliers to excel in all KPIs including Supplier owned quality, capacity, and sub-tier management.
- 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/SCAR documentation.
- Provide technical support for failure analysis of discrepant production components, assemblies, and field returns. Lead investigations where appropriate.
- Effectively prioritize and advance multiple concurrent projects and tasks.
- Clearly communicate project status to key stakeholders internally and in our supply chain.
Qualifications
Required Skills and Experience
- Experience in engineering and manufacturing of medical devices and the aviation industry.
- 5 years of experience in Supplier Development, Supplier Engineering, Supplier Process, or related field preferred.
- Excellent written and verbal communication skills in English (Full Bilingual), a natural team builder/leader.
- Excellent analytical and problem-solving skills along with good judgment.
- Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
- 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.
Required Education and Training
- BS degree in Electrical Engineering, Mechanical Engineering or equivalent.
- Knowledge of Six Sigma and Lean Manufacturing techniques, certification preferred.
- Knowledge of 21 CFR part 820 and ISO 13485 is a plus.
- Proficient in MS Office and ERP Information Systems, preferably SAP.
- Available for international travel (20% of the year) and have a valid visa
Working Conditions
- Ability to travel to suppliers on an as-needed basis – domestic and international.
Preferred Skills and Experience
- Experience in a high-volume medical device company is a plus.
- Knowledge of 21 CFR part 820 and ISO 13485 is a plus.
Additional Information
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
