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

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take the "no-shortcuts" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

A Product Development Engineer II at Tandem is responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of Tandem's new medical devices, test and assembly fixtures, and data collection systems.

A Product Development Engineer II at Tandem also:

• Participates in the research, development, modification, and reliability evaluation of medical device components and systems, applying engineering principles and knowledge of materials and component properties.
• Conducts mechanical design of medical devices and fixtures using SolidWorks, including rapid prototyping, design assessment, and tolerance analysis of parts and assemblies.
• Manages design verification and validation activities, including development of work instructions, test protocols, and test reports, and maintenance of associated documentation.
• Investigates and resolves design non-conformances and assembly process issues using root cause analysis and troubleshooting methodologies.
• Plans, designs, develops, and evaluates fixtures, equipment, and assembly processes, including CNC-machined components with consideration for manufacturability, machining limitations, and inspection requirements.
• Drives the design, development, qualification, and operational documentation of medical device pilot assembly lines.
• Designs and executes experiments, performs statistical analysis to evaluate process capabilities, and communicates results and conclusions.
• Participates in reviews of requirements, data, and process validation protocols/reports. Creates and reviews engineering drawings as needed using SolidWorks.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• Develops and manages development and testing at external test facilities/vendors as well as reviewing and assessing vendor capability to support development.

WHERE YOU'LL WORK:

This role is on-site five days a week at our San Diego office due to the nature of the work involved.

WHAT YOU'LL NEED:

• Bachelor's degree in mechanical engineering, biomedical engineering or related field or equivalent combination of education and applicable job experience.
• 2 years of product development experience in a heavily regulated industry, preferably in medical device.
• Ability to work effectively in a team environment and communicate technical knowledge to varying levels within organization.
• Exposure to testing methodology and data collection in a development environment is valuable.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Excellent written communication skills and experience with MS Office.
• Able to utilize statistical analysis techniques and tools to summarize data and support conclusions.
• Able to alter behavior and opinions in light of new information.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP).

EXTRA AWESOME:

• Ability to use SolidWorks to create and modify engineering models and drawings.
• Has working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Experience with medical device design, product development, and process development.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $85,000 to $100,000 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as a