Senior Mechanical R&D Engineer

We are seeking a hands‑on Senior Mechanical R&D Engineer to assist with detailed design and development of novel medical devices to create tissue access and deliver therapy in minimally invasive environments. This role emphasizes early‑stage R&D, intellectual property (IP) generation and design‑around innovation, with a focus on miniature boring, cutting, steering and deployment mechanisms integrated into sterile single‑use probes and catheter‑based platforms.

Stellartech utilizes a “multi‑physics” approach to develop therapeutic medical systems, and integrates mechanical, electrical, and software‑controlled elements that are optimized for the “clinical user environment”. The candidate will develop sophisticated medical devices from concept to market release. They will create and/or translate medical device product requirements into measurable engineering specifications, will help determine product and major sub‑system performance requirements, and perform the development and/or sourcing of these elements.

They will assist with all development activities required for clinical product use, including DMR creation, DHF preparation, product verification and validation testing, packaging design and verification, sterilization and biocompatibility validation, as well as assist with certification testing to internationally recognized Standards from ANSI/AAMI, ISO, ASTM, ASME, and the IEC. This is a technical leadership role for an engineer who thinks in mechanisms, materials, assembly methods, failure modes, and patent claims.

This position reports to the Vice President, Research and Development and will be a 100% on‑site position located in our Milpitas, CA facility.

• Create and/or translate customer requirements into measurable product specifications. Consider the application of collateral requirements, e.g., ASME fatigue requirements, IEC 60601 electrical safety requirements, etc.
• Design and develop mechanical systems to bore into, traverse, or access dense tissue in minimally invasive procedures with mechanisms that include rotational, axial and torque‑transmitting, and deflectable deployment systems for catheter and probe‑based devices.
• Perform detailed structural and fatigue analysis of the tissue‑interacting components, such as boring tips, cutting features, cannula design, and their mechanical interfaces.
• Consider performance, risks, manufacturability, materials, surface treatments, coatings, sterilization methods, and biocompatibility appropriate for dense tissue contact and wear.
• Develop detailed CAD models, drawings, and specifications suitable for prototyping, manufacturing, assembly and inspection.
• Assist with patent landscape reviews, design‑around analyses and IP defensibility related to device technologies. Design mechanical systems with claims scope in mind, including alternative embodiments. Drive multi‑path concept exploration to avoid single‑solution risk and strengthen patent coverage.
• Assist with benchtop, cadaver and in vivo testing in appropriate species to assess clinical and mechanical performance, including torque transmission, axial and radial load support, fatigue, wear, and failure‑mode characterization.
• Complete development of the product and perform and/or direct design verification and validation activities.

• Collaborate with Quality Engineering, Systems, Electrical and Software Engineering, Legal/IP, Clinical, Regulatory, and manufacturing teams during concept development.
• Contribute to risk management activities (DFMEA, Usability and use‑related hazards, mechanical failure modes, etc.).
• Support technology transfer to manufacturing, including DFM/DFA, supplier qualification, and first‑article inspection.
• Provide technical mentorship and thought leadership within the R&D organization.

• Bachelor's degree in Mechanical Engineering (Master's or PhD strongly preferred).
• 12+ years of medical device R&D experience, including early‑stage invention work and track record of successful product launches.
• Experience with catheter‑based or probe‑based delivery…