Sr. NPI Mechanical Engineer - Tooling

About the job

Job Description

Primary Function of the Position

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

Essential Job Duties

• Sustain and improve existing manufacturing lines:

• 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.

• Ideate, prototype, and implement simple, robust mechanical fixtures and tooling designed to error-proof complex assembly steps, take operator skill levels and manual technique out of the equation, and maximize production repeatability.

• 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.

• Support implementation of design improvements to existing products, including:

• 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)

• Contribute to the development of efficient manufacturing lines for New Product Introduction for medical devices for the daVinci SinglePort platform:

• 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. Examples include building prototype assemblies, training operators, identifying fixtures/tooling needed and conducting process validation.

• Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.

• Leadership Responsibilities:

• 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.