Medical Device Product Development Engineer II

Tandem Diabetes Care Europe B.V.; California; On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health benefits starting day one

401(k) with company match

11 paid holidays

20 days PTO with accrual

Job summary

Tandem Diabetes Care is seeking a Product Development Engineer II to contribute to the development, documentation, testing, analysis, troubleshooting, and debugging of Tandem's medical devices, test fixtures, and data collection systems.

You will participate in design verification/validation, root cause analysis, and the development of fixtures and assembly processes, including CNC components, with an emphasis on manufacturability.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering or related field, or equivalent experience.
• Minimum 2 years product development experience in a heavily regulated industry, preferably medical devices.
• Strong collaboration and communication skills across teams; data collection is valued.
• Experience with design verification/validation, testing methodologies and documentation.

Responsibilities

• Contribute to development, documentation, testing, analysis, troubleshooting, and debugging of medical devices, fixtures, and data systems.
• Conduct mechanical design using SolidWorks, including rapid prototyping and tolerance analysis.
• Manage design verification and validation activities and maintain related docs.
• Investigate design non-conformances and assembly issues via root cause analysis.
• Plan and evaluate fixtures, equipment, and CNC components with manufacturability in mind.
• Develop pilot assembly lines and perform statistical analysis on processes.

Skills

SolidWorks

Statistical analysis

Data collection

Root cause analysis

Team communication

GDP knowledge

GD&T knowledge

MS Office

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

SolidWorks

MS Office

Job description

Tandem Diabetes Care is seeking a Product Development Engineer II to contribute to the development, documentation, testing, analysis, troubleshooting, and debugging of Tandem's medical devices, test fixtures, and data collection systems.

You will participate in design verification/validation, root cause analysis, and the development of fixtures and assembly processes, including CNC components, with an emphasis on manufacturability.