Product Development Engineer II

Tandem Diabetes Care•California - High Bluff, CA

2d•$85,000 - $100,000•Onsite

About The Position

Tandem Diabetes Care is hiring a Product Development Engineer II to make technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of new medical devices, test and assembly fixtures, and data collection systems. The role participates in research, development, modification, and reliability evaluation of medical device components and systems, applying engineering principles and knowledge of materials and component properties. The engineer conducts mechanical design of medical devices and fixtures using SolidWorks, including rapid prototyping, design assessment, and tolerance analysis. The position manages design verification and validation activities; investigates design non-conformances and assembly process issues; plans and evaluates fixtures, equipment, and assembly processes; and drives the design, development, qualification, and documentation of medical device pilot assembly lines. It also involves designing and executing experiments, analyzing data statistically, participating in reviews, selecting components and equipment, and coordinating development and testing with external facilities and vendors. This position is based on-site five days a week at Tandem’s San Diego office. The starting base pay range is $85,000 to $100,000 annually, with pay varying according to job-related factors and location. Tandem offers a competitive compensation package that includes a bonus and benefits. Applicants must be authorized to work for any U.S. employer; visa sponsorship is unavailable. Employment is contingent on successful completion of a pre-employment drug test (excluding marijuana) and background check.

Requirements

Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field, or an equivalent combination of education and applicable job experience.
Two years of product development experience in a heavily regulated industry; medical device experience is preferred.
Ability to work effectively in a team environment and communicate technical knowledge to varying organizational levels.
Ability to assert ideas and persuade others by consolidating, evaluating, and presenting relevant information.
Excellent written communication skills and experience with MS Office.
Ability to use statistical analysis techniques and tools to summarize data and support conclusions.
Ability to adapt behavior and opinions in light of new information.
Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP).
Applicants must be authorized to work for any employer in the United States; the company cannot sponsor or take over sponsorship of a work visa.

Nice To Haves

Exposure to testing methodology and data collection in a development environment.
Ability to use SolidWorks to create and modify engineering models and drawings.
Working knowledge of federal and other regulations, such as QSRs, ISO 14971, and the IEC 60601 series.
Experience with medical device design, product development, and process development.

Responsibilities

Contribute technically to development, documentation, testing, analysis, troubleshooting, and debugging of new medical devices, test and assembly fixtures, and data collection systems.
Participate in research, development, modification, and reliability evaluation of medical device components and systems.
Conduct mechanical design of medical devices and fixtures using SolidWorks, including rapid prototyping, design assessment, and tolerance analysis of parts and assemblies.
Manage design verification and validation activities, including developing work instructions, test protocols, and test reports and maintaining related documentation.
Investigate and resolve design non-conformances and assembly process issues using root cause analysis and troubleshooting methodologies.
Plan, design, develop, and evaluate fixtures, equipment, and assembly processes, including CNC-machined components, considering manufacturability, machining limitations, and inspection requirements.
Drive the design, development, qualification, and operational documentation of medical device pilot assembly lines.
Design and execute experiments, perform statistical analysis to evaluate process capabilities, and communicate results and conclusions.
Participate in reviews of requirements, data, and process validation protocols and reports; create and review engineering drawings as needed using SolidWorks.
Select components and equipment based on analysis of requirements, component specifications, and reliability.
Develop and manage development and testing at external test facilities and vendors, and review and assess vendor capabilities.