Insightful Instruments · 19 hours ago
Senior Mechanical Engineer
Santa Clara, CA
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expInsightful Instruments is a small, early-stage medical device company based in Santa Clara, CA, developing innovative technology for refractive surgery. They are seeking a Senior Mechanical Engineer to play a key role in developing electromechanical systems and assisting with preclinical and clinical studies.
Medical Equipment Manufacturing
Hiring Manager
Michael Wiltberger
Responsibilities
Mechanical design of parts, assemblies, fixtures, & tooling for refractive surgery
Support benchtop & in vivo preclinical testing
Participate in collaborative definition of system architectures, brainstorming sessions, design reviews, & risk management meetings
Manage external consultants & work closely with key suppliers
Create & release design control documentation
Support compliance testing & regulatory submissions
Contribute to our IP portfolio
Qualification
Required
A collaborative, open nature
Comfortable working within a small, focused team that includes outside contractors in lead roles
Experience in: Medical devices & disposables
Experience in: Molded rigid & compliant polymer materials
Experience in: Design for biocompatibility
Experience in: Design, construction, testing, & release of prototype systems
7+ years of relevant experience within the medical device industry
BS in Mechanical Engineering
Proven success in bringing medical device products into clinical use
Preferred
Experience designing devices to interface with human anatomy
Experience with optomechanics
Experience in ophthalmology
Experience with micromolding
Experience designing electromechanical devices
Experience using OnShape
Experience with finite element analysis
An active inventor on at least one filed patent application
Programming experience with Matlab, Octave, LabVIEW, C, R, or Python
Experience adhering to regulatory standards such as ISO13485, ISO14971, & IEC60601
Company
Insightful Instruments
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase