Product Development Engineer II - Medical Devices (On-Site)

Tandem Diabetes Care, Inc.; Red Bluff (CA); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401k with company match

Employee stock purchase plan

Paid time off and holidays

Annual leave and benefits package

Job summary

Tandem Diabetes Care is seeking a Product Development Engineer II to contribute to the development, testing, and documentation of new medical devices and data collection systems. You will design fixtures and assemblies using SolidWorks and lead verification activities in a heavily regulated setting.

Required are a mechanical/biomedical engineering background and 2 years in regulated product development, plus strong communication and statistical analysis skills.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related field.
• 2 years of product development experience in a heavily regulated industry, preferably medical device.
• Ability to work effectively in a team and communicate technical knowledge.
• Exposure to testing methodology and data collection is valuable.
• Excellent written communication skills and MS Office experience.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and GDP.

Responsibilities

• Contributes to development, documentation, testing, analysis, troubleshooting, and debugging of medical devices.
• Designs fixtures and components using SolidWorks; conducts tolerance analysis.
• Manages design verification and validation activities with tests and documentation.
• Investigates design non-conformances and process issues via root cause analysis.
• Plans and evaluates fixtures, assembly processes, including CNC parts.
• Develops pilot assembly line documentation and data collection systems.

Skills

Teamwork in regulated environments

Communication of technical concepts

Problem solving

Regulated industry knowledge

Data interpretation

Education

Bachelor's degree in mechanical or biomedical engineering or related field

Tools

SolidWorks

MS Office

Job description

Tandem Diabetes Care is seeking a Product Development Engineer II to contribute to the development, testing, and documentation of new medical devices and data collection systems. You will design fixtures and assemblies using SolidWorks and lead verification activities in a heavily regulated setting.

Required are a mechanical/biomedical engineering background and 2 years in regulated product development, plus strong communication and statistical analysis skills.