Description
Come and be an early member of the Capstan Medical team. Bring a clinical value proposition to life, and help develop it into a successful product! This role will drive both sterilizable and disposable accessories for robotically controlled minimally invasive procedures.
Responsibilities
- Apply systems level problem solving at the intersection of clinical, instrument, and capital needs. Partner with neighboring assembly owners to negotiate and accommodate shifting interface specifications to iteratively improve the overall system performance.
- Dive into the details to bring craft and quality to design intersections in the clinic.
- Understand and enable clinical workflows, collaborating with clinical and systems engineers to create an awesome user experience.
- Proactively solicit, incorporate, and respond to needs within the mechanical disciplines as well as cross functional engineering stakeholders (manufacturing, software, systems, electrical). Build or source prototype and production units with materials, vendors, and methods scaled to project phases.
- Evaluate concepts in bench and pre-clinical tests. Document and capture outcomes within the design control process for quick iteration loops.
- Lead technical design reviews of accessories, presenting inputs, outputs, and risks for each product development stage.
- Execute verification and validation testing, generating associated protocols and reports to ensure product excellence.
Skills
- Proficient in Solidworks, creating detailed parts, assemblies, and drawings
- Clear and effective communication and documentation
- Proactive problem identification, communication, and solution generation
- Empathy and curiosity in design
- Complex tolerance analysis
- Medical device manufacturing, good manufacturing practices, and GD&T as appropriate.
- Familiarity with various manufacturing methods and hands on prototyping
- May include: polymer drapes, manual machining, 3D printing, molding, casting, coatings, etc.
- Practical mechanical mechanisms and assembly design
- Supplier selection, development, and management – tuned to project phases
- Quality Management system navigation
- Work collaboratively and efficiently in a fast-paced start-up environment.
- Comfortable working with ambiguity on the path to generating tangible outcomes.
- Experience with transfer to manufacturing, full scale manufacturing, and supplier development.
- Understanding of the medical device development process, design control, risk management, design verification, and regulatory processes.
- Experience with a productization cycle through V&V or similar
Requirements
- Engineering degree
- 5+ years of relevant industry experience or equivalent (medical device experience preferred, robotic system exposure preferred)
- On-site in Santa Cruz, CA
Overview
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment
At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, this gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment.