About the position
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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.
- 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 providing 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.
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.
Nice-to-haves
- Experience in mid-volume manufacturing of single-use devices or complex electro-mechanical assemblies.
- Experience in medical device design controls and manufacturing (ISO 13485).
- Machine tool experience.
Benefits
- Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
A Smarter and Faster Way to Build Your Resume