Lead R&D Engineer, Single-Use Medical Instruments

Calyxo; Pleasanton (CA); On-site; USD 175,000 - 190,000; Full time

Benefits offered by this job

Stock options

401(k)

Healthcare insurance

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA, is seeking an experienced engineer to lead the design and development of single-use kidney-stone treatment devices.

You will guide cross-functional teams from concept through commercialization, using SolidWorks for modeling and applying DFx to scalable designs. You will mentor engineers, drive design controls, and collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to push innovative concepts to launch.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field with 10+ years medical device experience, OR advanced degree with 9+ years.
• Work location: Pleasanton, CA.
• Travel: less than 10%.
• Full-time employment.
• Understanding of ISO 13485 and FDA 21 CFR Part 820.
• Experience leading technical teams and mentorship.
• Proven track record from concept to commercialization.
• DFX for manufacturability.
• Design in two or more areas: injection molding, electromechanical subsystems, catheter construction, endoscope construction, fluidics.
• SolidWorks proficiency; DFM, tolerance stack analysis, and GD&T.
• DOE with statistical analysis.
• Strong collaboration and hands-on testing.
• Experience CFD/FEA simulations.
• Experience in regulated industries and sterilization/biocompatibility testing.
• Vaccination compliance.

Responsibilities

• Lead design and development activities of new single-use devices and accessories as technical lead.
• Ensure design controls, manufacturability, reliability, and scalability with cross-functional partners.
• Create prototypes, fixtures, feasibility studies, and testing to guide product development.
• Solve engineering problems with root cause analysis and data-driven solutions.
• Define and lead qualification strategies for new designs or processes.
• Translate customer requirements into engineering specifications.
• Use SolidWorks to create models, assemblies, and drawings.
• Generate IP and contribute to the IP portfolio.
• Communicate progress, results, and risks to stakeholders.
• Develop test methods, protocols, and risk documentation.
• Coordinate with suppliers for component or subassembly development.
• Coordinate external testing such as sterilization and biocompatibility.

Skills

Leadership

Cross-functional collaboration

Mentorship

Design for manufacturability

GD&T

Root cause analysis

DOE / statistics

Problem solving

Team communication

Education

Bachelors in Mechanical/Biomedical Eng

Advanced degree (MS/PhD)

Tools

SolidWorks

Job description

Calyxo, Inc. in Pleasanton, CA, is seeking an experienced engineer to lead the design and development of single-use kidney-stone treatment devices.

You will guide cross-functional teams from concept through commercialization, using SolidWorks for modeling and applying DFx to scalable designs. You will mentor engineers, drive design controls, and collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to push innovative concepts to launch.