Product Development Engineer I (Temporary - 6 Month Contract)

Tandem Diabetes Care•Irvine, CA

13d•$35 - $44•Onsite

About The Position

Tandem Diabetes Care is seeking a Product Development Engineer I for a temporary, 6-month contract position. This role involves testing, building, designing, and documenting the company’s next-generation medical devices, test and assembly fixtures, and data collection systems. The company focuses on creating innovative products for people with diabetes, with a human-centered approach and a team that often has personal connections to the cause.

Requirements

Experience with testing methodology, data collection, and data analysis in a development environment.
Ability to communicate technical knowledge to varying levels within organization.
Capable of using statistical techniques and tools to summarize data and support conclusions.
Knowledge of Good Documentation Practices (GDP).
Excellent written communication skills.
Familiar with medical device design and product development.
Familiar with mechanical design of fixtures using Solidworks.
Familiar with part tolerances and analyzing tolerances of assemblies and processes.
Able to work effectively in a team environment at all levels within the organization.
Experience with MS Office.
Bachelor’s degree in mechanical engineering, biomedical engineering or equivalent combination of education and applicable job experience.
At least 6 months of product development experience in the medical device field.

Responsibilities

Develops test methods, performs design verification testing & verifies performance with Gage R&R studies
Writes detailed and easily understood work instructions, test protocols, test methods, and test reports
Uses statistical analysis to interpret test data in support of design verification and validation
Troubleshoots product design and assembly processes
Participates in the development of mechanical components and systems for the company’s medical devices
Mechanical design of test fixtures and medical devices using SolidWorks
Builds and assesses mechanical designs using rapid prototyping technologies
Works within design controls and contributes to the design history file for medical devices by reviewing product requirements and specifications, documenting the design process, participating in formal design reviews, and verifying the product performance with formal test methods, protocols, and reports.
Performs competitive product analysis and contributes to the development of product requirements
Performs tolerance analysis of mechanical designs
Conducts and participates in design reviews
Supports transfer of design to manufacturing
Confirms completion of required training plan before assuming job responsibilities
Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements
Other responsibilities as assigned