Lead Instrumentation R&D Engineer - Medical Devices

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

Benefits offered by this job

Stock options

Healthcare insurance

401(k) plan

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA is developing a single-use kidney stone treatment device.

The Instruments Engineering team leads design and development from concept through launch, integrating mechanical systems with vision, sensors, and software to advance novel concepts to commercialization. You will collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to translate customer requirements into engineering specifications; use SolidWorks for models and drawings; contribute

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering; 10+ years medical device experience.
• Advanced degree in related field; 9+ years medical device experience.
• Work location: Pleasanton, CA.
• Travel: less than 10%.
• Full-time employment.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience leading technical teams and mentoring engineers.
• Proven track record from concept to commercialization.
• Ability to apply DFX principles to scalable designs.
• Experience in injection molding, electromechanical subsystems, catheter construction, or endoscope construction, or fluidics.
• SolidWorks proficiency; tolerancing and GD&T.
• DOE and statistical data analysis experience.
• Strong collaboration and communication skills.
• Hands-on product development and testing.
• Simulation experience (CFD, FEA) to inform design.
• Experience in regulated industries; knowledge of sterilization and biocompatibility testing.
• Vaccination compliance with county, state, and federal rules.
• Legal authorization to work in the United States.

Responsibilities

• Lead design and development activities of new single-use devices and accessories, as technical lead and core team lead.
• Ensure design and development pathways adhere to design control, enabling manufacturability and reliability.
• 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.
• Drive supplier communication for component development.
• Coordinate external testing such as sterilization, packaging, and biocompatibility.

Skills

Leadership

Cross-functional collaboration

Problem-solving

DOE

CFD/FEA simulations

Statistical analysis

Regulatory knowledge

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Advanced degree in related field

Tools

SolidWorks

Job description

Calyxo, Inc. in Pleasanton, CA is developing a single-use kidney stone treatment device.

The Instruments Engineering team leads design and development from concept through launch, integrating mechanical systems with vision, sensors, and software to advance novel concepts to commercialization. You will collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to translate customer requirements into engineering specifications; use SolidWorks for models and drawings; contribute