Staff NPD Engineer – Flexible Endoscopes
IntuitiveAbout the role
Company Description
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.
Job Description
The Staff Design Engineer will drive all technical aspects of next gen catheter steerable catheter and flexible endoscope designs at Intuitive for Ion. The Ion™ endoluminal system is Intuitive's robotic platform for minimally invasive biopsy in the peripheral lung with an initial goal of improving the early diagnosis of lung cancer. Ion accesses deep into the lungs and offers treatment not possible with conventional tools.
Roles & Responsibilities:
- Guide all design deliverables for derivative and breakthrough steerable catheter and endoscope projects.
- Create novel designs that meet the needs of all stakeholders including clinical and manufacturing
- Test early phase devices to identify risks, root causes and appropriate design related solutions
- Quickly assess design options and necessary activities to drive outcomes based on sound engineering practices and data
- Develop Test Methods and identify appropriate level of testing such as sample size and limit/challenge testing to ensure design is robust and capable of meeting requirements for a wide variety of process and clinical conditions
- Complete detailed drawings and robust tolerance analysis and update designs accordingly.
- Organize and evaluate data and schedule periodic technical reviews to present findings, conclusions and next steps to piers and stakeholders
- Work closely with Clinical, Supply Chain and Manufacturing to establish requirements, metrics and assess tradeoffs and progress
- Engage Manufacturing Engineering, Equipment Engineering and production to help develop robust processes for high volume and cost effective manufacturing
- Partner with design control engineer to follow all Design control SOPs and complete design control deliverables including requirements, risk analysis and Design V&V testing
- Provide design and process support and continued sustaining support during the early phases of manufacturing
- Maintain close ties to RMA and field complaints to assess potential design related changes that may be needed
Qualifications
The successful candidate will have an excellent background in catheter design and processes, including braiding, laminating, laser welding, and Injection molding. The candidate must have a proven track record of designing, building and testing catheter designs from initial concept to manufacturing transfer. The candidate must have a solid Engineering background with experience in CAD, FEA and Materials have demonstrated ability to use these tools for designing many of the components needed for a complex steerable catheter. The candidate should be comfortable with hands on building and testing, but also have a sound understanding of the engineering theory behind such devices.
Skills, Experience, Education, & Training:
- Minimum BS Mechanical Engineering or related engineering discipline required, MS or Higher Preferred. Advanced degrees may substitute for experience
- Minimum 10 years of experience developing commercial medical products, at least 5 yrs of steerable catheter design experience
- Thorough understanding of the state of the art of steerable catheters or flexible endoscopes.
- Thorough understanding of the state of the art at design and manufacturing houses for catheter components such as extrusions, braiding, mandr
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