Sr. NPI Mechanical Engineer - Tooling

Intuitive•Sunnyvale, CA

About The Position

The Sr. NPI Mechanical Engineer contributes mechanical, manufacturing, and problem-solving expertise to a team developing precision instruments for the da Vinci SinglePort platform. The role supports manufacturing lines for both mature and new products, providing day-to-day engineering support, driving continuous improvement, and developing manufacturing equipment and assembly processes for new products. The engineer designs and implements mechanical fixtures and tooling to improve product quality, throughput, cost, and repeatability; investigates assembly defects; supports quality-system activities; and troubleshoots manufacturing equipment and processes. The position also supports product design improvements, line transfers and duplication, supplier changes, and equipment and process qualification. For new product introduction, the engineer develops assembly and test fixtures and processes, documents and qualifies manufacturing methods, specifies bills of materials and work instructions, and collaborates with cross-functional teams through verification, validation, and product launch. The role also provides project leadership, mentors manufacturing engineers, establishes project milestones and success criteria, and helps maintain stakeholder alignment.

Requirements

Bachelor’s degree in Mechanical Engineering or a related technical discipline.
At least 8 years of experience with a bachelor’s degree, or at least 6 years with a master’s degree, as a process or manufacturing engineer supporting products with significant mechanical content.
Proven experience designing complex mechanical fixtures and custom tooling for precision manufacturing environments.
Hands-on experience developing custom tooling for integration with standard manufacturing equipment such as presses, crimpers, heat stakers, and ultrasonic welders.
Strong knowledge of mechanical design principles, fabrication methods, material selection, and surface treatments for tooling.
Strong 3D modeling/CAD experience; SolidWorks is preferred.
Expert application of GD&T, tolerance stack-up analysis, and proficiency in FEA modeling.
Experience with design, fabrication, and assembly process development for complex mechanical assemblies.
Understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.
Technical problem-solving skills, including identifying root causes and driving corrective action using methods such as Fishbone and 8D analysis.
Ability to use statistical methods such as Cpk, ANOVA, and Design of Experiments for data analysis, process development, and problem-solving.
Effective verbal, written, and presentation communication skills, including the ability to interact with production technicians, product design engineers, planning, buyers, clinical engineers, and suppliers.
Ability to lift, maneuver, and troubleshoot fixtures and tools.

Nice To Haves

Master’s degree in Mechanical Engineering or a related technical discipline.
Experience in mid-volume manufacturing of single-use devices or complex electromechanical assemblies.
Experience with medical-device design controls and manufacturing, including ISO 13485.
Machine tool experience.

Responsibilities

Provide daily engineering support for existing in-house manufacturing lines.
Drive continuous improvement of mechanical fixtures and processes to improve product quality, throughput, and cost.
Use objective data and statistical analysis to inform decisions.
Design, prototype, and implement robust mechanical fixtures and tooling that error-proof complex assembly steps and improve repeatability.
Lead root-cause investigations and determine dispositions for assembly-related defects, using Product and Process FMEAs as guidance.
Support quality-system compliance, including ECO review and implementation, discrepant material dispositions, nonconformance evaluations, and quality notifications.
Troubleshoot, resolve, and document equipment and process malfunctions in accordance with GXP and Intuitive Quality System requirements.
Assist with manufacturing line transfers and duplication.
Provide Design Engineering feedback on Design for Manufacturability and Assembly (DFM/DFA).
Lead Design Verification and Validation (V&V) builds and coordinate production implementation of design changes.
Provide manufacturing feedback for supplier change requests.
Support equipment and process qualification, including IQ/OQ/PQ and PPQs.
Design and implement assembly and test fixtures for new product manufacturing, including complex joining and general assembly operations.
Develop, document, and qualify new manufacturing and test processes using statistical tools such as DOE, Cpk, and test method validation.
Specify and refine bills of materials, workflows or travelers, and detailed work instructions.
Collaborate with Production, Design Engineering, Quality Engineering, Supplier Engineering, and Project Management to meet project objectives and support product launch.
Build prototype assemblies, train operators, identify required fixtures and tooling, and conduct process validation.
Create and revise manufacturing risk and specification documents, including Process FMEAs, Manufacturing Line Specifications, and Equipment Specifications.
Lead or participate in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and continuity of material supply.
Mentor Manufacturing Engineers and assign project tasks as needed.
Establish milestones, support, and success criteria for assigned projects.
Drive decisions, escalate key issues promptly, and maintain stakeholder alignment.
Travel periodically to suppliers or Intuitive manufacturing sites as needed.