NPI Manufacturing Engineer
| Company | Intuitive Surgical |
|---|---|
| Location | Sunnyvale, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
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.
Responsibilities
- Provide daily engineering support for existing in-house manufacturing lines for NPI product line and mature manufacturing lines
- Drive 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.
- 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.
Preferred Qualifications
- 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.