What are the responsibilities and job description for the Senior Mechanical Engineer position at Insightful Instruments?
Background
Based in Santa Clara, CA, Insightful Instruments is a small, early-stage medical device company operated by serial medical device founders with a track record of building businesses and new markets. Insightful is developing its patented PlasmaWire technology to transform refractive surgery and plans to extend it to other indications. The company has operational prototypes and is moving along a preclinical path, including in vivo use in an animal model, and is refining the nuanced aspects of its product design, with plans to start its first-in-human clinical study near the end of 2026. We are hiring a Staff or Senior Mechanical Engineer to play a key role in developing our electromechanical systems and assisting with preclinical and first-in-human clinical studies. We offer a compensation package commensurate with experience.
Responsibilities:
Specific responsibilities include, but are not limited to:
- 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
Requirements:
- A collaborative, open nature
- Comfortable working within a small, focused team that includes outside contractors in lead roles
- Experience in:
- Medical devices & disposables
- Molded rigid & compliant polymer materials
- Design for biocompatibility
- 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
The following is advantageous:
- 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.