Overview:
The Senior R&D Engineer will take a prototype second generation delivery system architecture into pilot production, DV testing, and to clinical trials. The candidate will work closely with the delivery system, operations, and implant teams to ensure a holistic product design and development approach. The candidate will facilitate engineering processes and product transfer to a cleanroom manufacturing environment.
Responsibilities:
- Work closely with R&D, manufacturing and clinical teams to bring a complex catheter-based delivery system to early clinical studies and beyond.
- Combine R&D and Manufacturing perspectives to implement elegant and practical changes.
- Figure out how to build the product, and then design to make better and more buildable:
- Empowered to change the design!
- Identify process gaps and inefficiencies
- Develop suppliers to meet specifications
- Evaluate, capture, and communicate the impact of implemented solutions
- Communicate system level integration challenges, support solution development and implementation
- Understand and prioritize between multiple workflows and feedback sources
- Identify performance issues, track root causes
- Develop and execute test methods to inform process and design decisions
- Assist in development of product specifications
Requirements:
- BS in mechanical engineering or relevant field
- 5+ years of experience of relevant engineering experience
- Experience with catheter based medical devices is strongly desired
- Proficiency in CAD, preferably SolidWorks, including 3D design and creation of technical prints
- Experience with various manufacturing methods, such as manual machining, 3D printing, MIM, molding, casting, laser welding, reflow, coatings, etc.
Skills Desired:
- Demonstrated ability to take early designs into successful small-scale production and beyond
- Hands on prototyping and testing experience
- Proficiency and familiarity with machining processes from simple on the fly reworks to guiding high level design for manufacturability decisions
- Familiarity with force sensing equipment (e.g. Chatillon, Instron) is a plus
- Strong organization and project management skills
- Hands-on experience working within a quality management system (QMS)
- Great troubleshooting skills and creative problem solving
- Ability to compile results using applicable software (e.g. Excel, Minitab)
- Strong communication and collaboration
About us:
Occam Labs is an engineering incubator targeting early-stage medical device design. We focus on cultivating cutting edge technology centered on patient value. Our team is highly collaborative and hands-on, takes pride in iterating quickly, and believes that the best ideas can come from anywhere or any person! We always have multiple programs in the pipeline so, as a small team, we tend to wear multiple hats on a daily basis.
Occam Labs is uniquely positioned in Santa Cruz, which we have chosen to be geographically close-to but intentionally separate from the greater SF Bay Area. 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 located in a repurposed warehouse space that used to be the Wrigley Gum factory, now home to several bicycle companies, many art and architecture studios, a maker space, and several biotech startups. It 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.
Currently, our active programs at Occam Labs target catheter-based repair devices for diseases that affect the heart. These kinds of devices present patients with compelling, minimally invasive alternatives to traditional surgical methods. For most patients, this means less pain after surgery and being able to return to normal life much more quickly. For many older patients, reducing surgical trauma can make the difference between life and death. Our current strength is in micro-scale mechanical medical devices on the cutting edge of medicine but we are constantly evolving. The team has a collective background designing a wide variety of medical devices including cardiac devices, catheter-based devices, collapsible implants, surgical tools and robotic systems.
