NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

2d•Onsite

About The Position

Contribute your technical manufacturing, design, and problem-solving skills to a dynamic team creating precision instruments for the da Vinci SinglePort (SP) platform. This highly skilled manufacturing engineer will help with the roll out of a new MES (Manufacturing Execution System) system for SP Instruments and Accessories products and then support manufacturing lines for both mature and new products. Responsibilities include providing daily support for existing manufacturing lines, continuous improvement efforts, as well as developing manufacturing equipment and assembly processes for new and existing products.

Requirements

Strong 3D modeling/CAD experience (SolidWorks preferred)
Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.
Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.
Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments,) in data analysis for process development and problem-solving.
Effective communication skills (verbal, written, and presentation) and comfortable interacting with production technicians, product design engineers, planners, buyers, clinical engineers, supplier engineers, and upper management.
Able to travel periodically to suppliers or Intuitive manufacturing sites.
Minimum B.S. Mechanical Engineering or related technical discipline.
5+ years with a B.S, or 3+ years, with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.

Nice To Haves

Experience in mid-volume manufacturing of single-use devices or complex electro-mechanical assemblies is a plus.
Experience in medical device design controls and manufacturing (ISO 13485) is a plus.
Machine tool experience is a plus.

Responsibilities

Support the roll out of a new MES (Manufacturing Execution System) system for SP Instruments and Accessories products: Update Bill of Materials and Manufacturing travelers, Qualify equipment (IQOQPQ) that requires updating due to MES system transition, Update other process documentation related to the new MES system as required.
Be the subject matter expert for all the engineers in the SP Instruments and Accessories Process Engineering Organization on using the new system.
Be the voice of manufacturing engineering in all system improvements.
Support system level testing.
Execute the task above for all Single Port Instrument and Accessories projects.
After MES rollout, support Single Port Core Instruments Products
Provide daily engineering support for existing in-house manufacturing lines for NPI product line and mature manufacturing lines
Lead root cause investigations and drive dispositions and corrective actions for assembly-related defects using Product and Process FMEAs as guidance for various non conformances.
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 compliance with GXP and Intuitive Quality System requirements.
Assist in line transfer and line duplication activities.
Support equipment and process qualification efforts (IQOQPQ and PPQs)
Own and drive continuous improvement of product quality, throughput, and cost.
Utilize objective data and statistical analysis to inform and drive decisions.
Projects included Manufacturing Process Instruction updates, Test Method Validations, equipment and aid design, line balancing efforts, capacity improvement projects, etc; and the documentation required
Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R.
Specify and refine BOMs, workflows, and manufacturing travelers
Revise manufacturing related risk documents including Process FMEAs, Manufacturing Line Specifications, and Equipment Specifications
Support implementation of design improvements to existing products, including: Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA), Assist in Design Verification and Validation (V&V) builds, Coordinate cut-in/implementation in production.
Provide manufacturing feedback for supplier change requests (SCRs).
Support the task/responsibilities above related to new product introductions.