Sr NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

About The Position

Contribute your technical manufacturing, design, and problem-solving skills to a dynamic team creating precision instruments for the daVinci SinglePort (SP) platform. This highly skilled manufacturing engineer will 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 products.

Requirements

Strong 3D modeling/CAD experience designing complex mechanical fixtures and equipment (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, planning, buyers, clinical engineers, and suppliers.
Able to travel periodically to suppliers or Intuitive manufacturing sites.
Minimum B.S. Mechanical Engineering or related technical discipline. M.S. preferred.
8+ years with a B.S or 6+ years with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.
Ability to lift, maneuver, and troubleshoot fixtures and tools.

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

Provide daily engineering support for existing in-house manufacturing lines.
Own and drive continuous improvement of mechanical fixtures and processes to improve product quality, throughput, and cost.
Utilize objective data and statistical analysis to inform and drive decisions.
Lead root cause investigations and drive 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 compliance with GXP and Intuitive Quality System requirements.
Assist in line transfer and line duplication activities.
Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA).
Lead Design Verification and Validation (V&V) builds.
Coordinate cut-in/implementation in production.
Provide manufacturing feedback for supplier change requests (SCRs).
Support equipment and process qualification efforts (IQOQPQ and PPQs).
Design and implement assembly/test fixtures to increase repeatability of complex assembly operations including cable routing, plastics joining (e.g. ultrasonic welding, heat staking, snap fit, press fit), metals joining (e.g. laser welding, riveting, swaging, crimping), and general assembly.
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 Test method validation.
Specify and refine BOMs, workflows/travelers, and detailed work instructions.
Collaborate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to meet project objectives including Design Verification & Validation and product launch.
Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.
Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining continuity of material supply.
Mentors and sets project tasks for Manufacturing Engineers on their specific project team, and on other teams as needed, to further company expertise & effectiveness.
Establish milestones, support, and success criteria for responsible projects.
Drive decisions and escalate key issues quickly maintaining stakeholder alignment.
Keep the organization’s vision and values at the forefront of decision-making and action.