Senior Manufacturing Engineer

Job description

Primary Function of Position At Intuitive, we believe that minimally invasive care is life-enhancing care. We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients. We use creative techniques to solve hard problems to achieve optimal clinical performance, manufacturabilty, business objectives, and reliability.

Within Intuitive, the Single Port robotic platform offers surgeons the ability to perform surgeries through a single incision with boundless possibilities. This Manufacturing Engineer will effectively collaborate with core team partners and individually contribute to sustaining and improving existing manufacturing processes to achieve operational excellence.

Essential Job Duties

Lead duplication, line transfer, and operational manufacturing line activities. Provide daily engineering support for existing in-house manufacturing lines. Execute continuous improvement projects for product quality, throughput, and cost. Utilize analytical objective data and statistical analysis to establish metrics and to inform goals and priorities. Lead root cause investigation and drive dispositions for assembly-related defects.

• Support implementation of design improvements to existing products, including: Lead Design Verification and Validation (V&V) builds
• Coordinate cut-in/implementation in production
• Design and implement assembly/test fixtures to optimize cycle time, repeatability and consistency of complex assembly operations.

Specify and refine BOMs, workflows/travelers, and detailed work instructions. Collaborate and communicate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to sustain and optimize processes and line performance. Create and revise manufacturing-related validation and risk documents including IQ/OQ/PQ/PPQ protocols, Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.

Qualifications

Required Skills and Experience

Strong 3D modeling/CAD experience (SolidWorks preferred) Foundation in design, fabrication, and assembly process development for complex mechanical assemblies. Familiarity and experience with the application of lean principles. Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis) Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.

Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solving. Effective communication skills in Spanish and English (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.

Required Education and Training 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.

Preferred Skills and Experience

Experience in mid-volume manufacturing of single-use and resposable medical 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.