Supplier Engineer

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 for the China Operations organization is to ensure High Quality and Stable Delivery of purchased production components from suppliers operating under Mature and Stable Quality Management Systems to maximize Patient Value. These suppliers will be local sources in China ideally and global supply chain sources where required. The Supplier Engineer is responsible for ensuring suppliers meet ISI and ISFMT (Intuitive Surgical / Fosun Medical Technology) requirements for product safety, quality, cost, capacity, delivery, and service; driving suppliers to continuously improve business and manufacturing processes. Additionally, this role serves as a liaison between the ISFMT SE organization and the ISI SE organization; therefore, there will be mutual suppliers and actions across both sites.

Roles and Responsibilities:

Supplier Quality and Process Development

• Partner with ISFMT SEs and ISI SEs at assigned suppliers using various tools and best practices including project management, Six Sigma, Lean and SPC.
• Include Change Control Management using Supplier Change Request (SCR) process, Engineering Change Order (ECO), and/or Process Change Notice (PCN).
• Perform and maintain product/process risk analyses and ensure mitigations are implemented and effective (Supplier Process FMEA).
• Establish and sustain capable processes at supplier sites.
• Work jointly with ISFMT SE to implement supplier manufacturing process selections.
• Help the ISFMT and Intuitive teams in overcoming difficult process issues encountered in the manufacture of components and assemblies.
• Investigate and resolve ISFMT Production line down events that are supplier caused.
• ISI-owned component/assembly drawing or MPI discrepancy corrections.
• Drive Inspection Correlation analyses and corrections between ISFMT, ISI and suppliers.
• Disposition non-conforming material (Containment).
• In-depth Root Cause Analysis.
• Implement Corrective Actions/Preventive Actions.
• Capture all ISI and ISFMT record evidence of CAPA actions.
• Partner with ISFMT SE to provide effective and timely supplier health information (Supplier Monitoring) to ISI and ISFMT management and the supplier through Scorecards, Strategic Business Reviews, and Quality Feeder meetings.
• Engage with ISFMT SE to help Production Part Qualification Process (PPQP) deliverables.
• This includes PPQP actions for NPI new part releases, and for Sustaining Production version updates.

Supplier Selection and Evaluation

• Participate in the ISFMT Supplier Selection Evaluation team and ensure all quality aspects of the intended supplier are considered; actions may include:
• Control Plan audit.
• QMS audit.
• First Article Inspection.
• Special Process Validation.
• Process Capability Research.
• Partner between ISFMT Purchasing/Materials organization and ISI Purchasing/Materials organization with respect to supplier selection, evaluations, onboarding, and monitoring.
• Lead Auditor or Backup Auditor functions in helping of ISFMT 13485 audit requirements. These audits may include ISI auditing ISFMT, or ISFMT auditing ISI, or ISFMT auditing suppliers.
• Audit can be regularly scheduled QMS audit or for-cause audit based on performance issues.
• Drive ISI and supplier SCAR processes to resolve non-conformities.
• SCARs may include those issued by ISI to ISFMT, or ISFMT to ISI, or to suppliers.

Qualifications

Skill/Job Requirements:

• Minimum BS degree in Engineering or equivalent.
• 3-6 years related experience in Manufacturing Engineering, Supplier Engineering, or related field.
• Experience utilizing project management skills
• Experience in analytical and trouble-shooting skills, and inspection and test techniques.
• Ability to read and interpret detailed specification drawings and communicate technical information.
• Experience in evaluating and supporting supplier-related issues.
• Knowledge of Supplier Process FMEA and Process Validation.
• Experience with manufacturing processes including understanding of key input variables for quality, cost, and capacity.

Preferred Skills

• Computer experience using Windows, MS Office Suite, SAP (or other ERP system), and Agile (or other PLM system).
• Ability to travel to suppliers on an as needed basis - domestic and international (max travel per quarter is 30%).
• Flexible working hours to help China Operations organization.
• Verbal fluency in Mandarin Chinese would be a plus.
• Knowledge of Six Sigma and Lean Manufacturing techniques.
• Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards).
• CAD experience with 3D modeling tools or schematic capture tools.
• Experience in a high-volume medical device company.

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

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 salary ranges are listed.