Senior Consumables Engineer - High-Volume Medical Devices

Outset Medical, Inc.; Tijuana; On-site; MXN 700,000 - 900,000; Full time

Job summary

Outset Medical, Inc. is a medical device company pioneering the Tablo Hemodialysis System, based in San Jose, CA with global manufacturing in Tijuana, MX. The Senior Consumables Engineer will lead design, testing and process validation for high-volume disposable products used in clinical settings.

You will collaborate across QA, Regulatory, and Manufacturing, applying DOE, statistics, and DFx to deliver robust, cost-effective disposables. Onsite in Tijuana, international travel is expected.

Qualifications

• SBS in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related technical discipline.
• 5-7 years of design and development experience in the medical device industry.
• Experience supporting development of disposable medical products.
• Knowledge of PPAP/IQ/OQ/PQ and FDA QSR, GMPs, ISO 13485.
• Experience with statistical methods and tools such as Minitab.
• DOE, process capability analysis, and statistical sampling.

Responsibilities

• Design and develop disposable products through to production.
• Create 3D CAD models and detailed drawings with low-cost manufacturing focus.
• Lead design development from concept to production.
• Evaluate manufacturability with suppliers and QA.
• Develop materials, components, and packaging for sterile disposables.
• Support qualification, inspection methods, and automation initiatives.
• Generate test plans and reports; oversee testing.
• Apply statistics to analyze data and drive decisions.
• Collaborate with suppliers and manufacturing to ensure process capability.
• Document designs for ISO 13485 and FDA filings.
• Travel ≈10% internationally.

Skills

Mechanical engineering

3D CAD

Design for manufacturability

Statistical methods

FDA/ISO13485 knowledge

Education

B.S. in Mechanical Engineering

Tools

SolidWorks

Minitab

Job description

Outset Medical, Inc. is a medical device company pioneering the Tablo Hemodialysis System, based in San Jose, CA with global manufacturing in Tijuana, MX. The Senior Consumables Engineer will lead design, testing and process validation for high-volume disposable products used in clinical settings.

You will collaborate across QA, Regulatory, and Manufacturing, applying DOE, statistics, and DFx to deliver robust, cost-effective disposables. Onsite in Tijuana, international travel is expected.