Biocompatibility Engineer Jobs (NOW HIRING)

About Us

Founded in 1988, and headquartered in Milpitas, CA, Stellartech Research Corporation (SRC) is a world leader in the development of innovative devices for both large, established companies and early-stage start-ups in the medical industry. The medical systems we develop, and manufacture typically combine a complex electronic microprocessor-controlled device and a “smart” disposable. They employ cutting edge technology such as highly sophisticated energy delivery modalities, cloud-based wireless communication and advanced imaging capability. Our commitment to a “Multiphysics” approach and the mastery of the scientific principles necessary for design realization has allowed us to achieve medical breakthroughs and pioneer many “firsts” in the industry. These include the first temperature-controlled RF generator for cardiac ablation, the first monopolar capacitive RF tissue remodeling system for cosmetic use, and the first balloon-based system for esophageal ablation. With over 25 years of success, we’re continually developing new ideas to serve specialized markets in the medical industry.

Position Summary

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 with a focus on miniature boring, cutting, steering and deployment mechanisms integrated into sterile single-use probes and catheter-based platforms. Candidate shall be capable of fabricating and sourcing components for these devices, including light machine shop fabrication and rapid prototyping resources.

The candidate will develop sophisticated medical devices from concept through verification testing. They will help determine product and major sub-system performance requirements, and perform the development and/or sourcing of these elements, DMR creation, DHF documentation input, product verification and validation testing, packaging design and verification, and sterilization and biocompatibility validation. Candidate shall be familiar with internationally recognized Standards from ANSI/AAMI, ISO, ASTM, ASME, and the IEC. This is a hands-on technical role for an engineer who thinks in mechanisms, materials, assembly methods and failure modes.

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

Core Responsibilities – Technical Product R&D and IP Development

• 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.
• Generate detailed CAD models, drawings, and specifications suitable for prototyping, manufacturing, assembly and inspection.
• Assist with benchtop and in vivo testing in appropriate model to assess 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.

Cross-Functional Collaboration

• Collaborate with Quality and Manufacturing Engineering 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.

Required Qualifications

• Bachelor's degree in Mechanical Engineering (Master’s or PhD strongly preferred).
• 8+ years of medical device R&D experience and track record of successful product developments.
• Experience with catheter-based or probe-based delivery systems.
• Familiarity with dense tissue mechanics, cutting forces, and material interactions.
• Experience with rotational torque transmission in flexible or semi-flexible shafts.
• Familiarity with regulatory requirements pertinent to medical device development, including US FDA Quality System Regulations, 21 CFR Part 820, Design Controls and Good Manufacturing Practices (GMP’s), international standards such as EN 13485 and ISO 14971, etc.
• Advanced proficiency in 3D CAD (SolidWorks).
• Hands on experience with fabrication equipment, including mill, lathe, laser welder, boring, cutting, extrusion, injection molding, adhesive bonding, ultrasonics assembly, etc.
• Familiarity with engineering materials used is disposable medical devices.
• Familiarity with standard laboratory practices and test equipment, such as multimeters, oscilloscopes, tensile testers, strain gauges, pressure gauges, thermocouples, etc.
• Experience with transfer into manufacturing, including equipment, tooling and fixture design and fabrication, process development, operator training, process validation and manufacturing documentation, including Device Master Records, Manufacturing Procedures, Quality Instructions, and Test Procedures.
• Ability to communicate ideas and information clearly and effectively, i.e. good verbal and writing skills.
• Team-oriented professional with good interpersonal skills who is hands-on.

Compensation & Benefits

Salary Range: $150,000 - $190,000

The posted range represents the company’s good-faith estimate for base salary for this role at the time of posting. Actual compensation will be determined based on relevant factors such as skills, experience, education, and internal equity.

Benefits: We offer a competitive benefits package to our full-time employees, including medical, dental vision, life and disability insurance, and paid time off. In addition, Stellartech offers a 401(k) plan with company match and a stock equity plan.