Senior Supplier Process Engineer – Medical Devices

Intuitive; Sunnyvale (CA); On-site; USD 158,000 - 186,000; Full time

Job summary

Intuitive Surgical is seeking an experienced supplier quality and engineering professional to drive supplier performance for metal injection molding and related manufacturing processes. You will lead supplier qualification, CAPA, and cost improvements while coordinating with engineering for new product introductions and NPI execution.

The role emphasizes supplier excellence, data-driven decision making, and adherence to 21 CFR 820 and ISO 13485 standards in a global medical device setting.

Qualifications

• BS degree in Mechanical or Biomedical Engineering or equivalent experience; advanced degree preferred.

Responsibilities

• Ensure suppliers meet ISI requirements for quality, service, delivery, and cost.

Skills

Engineering expertise in MIM/metal/plà

Supplier qualifications & audits

Lean/6 Sigma/SPC

Project management

Analytical/problem solving

Executive-level communication

Interpersonal/team building

Supplier development & management

Quality/cost/capacity analysis

Process capability & CAPA

Knowledge of 21 CFR 820/ISO 13485

ERP/SAP or Agile experience

CAD modeling (3D)

Minitab or statistical tools

GD&T interpretation

Domestic/international travel 25%

High-volume medical device experience

Education

BS in Mechanical or Biomedical Engineering (or equivalent)

Tools

SAP

Microsoft Project

MS Excel

CAD software

Minitab

ERP systems

Agile

Job description

Intuitive Surgical is seeking an experienced supplier quality and engineering professional to drive supplier performance for metal injection molding and related manufacturing processes. You will lead supplier qualification, CAPA, and cost improvements while coordinating with engineering for new product introductions and NPI execution.

The role emphasizes supplier excellence, data-driven decision making, and adherence to 21 CFR 820 and ISO 13485 standards in a global medical device setting.