Sr Product Development Engineer I

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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

On-Site: This role is typically on-site five days a week at our Irvine office due to the nature of the work involved. Occasional travel to San Diego may also arise. 

Travel: This role may require car and air travel up to 10% of time including potential international travel.

A DAY IN THE LIFE:

As a member of the product development team, the Sr. Product Development Engineer I will be a key contributor to the design and development of the Company’s new and existing products including insulin pumps, disposables, and accessories.  This team member is expected to contribute to the hardware development and support the team through the design development process including all aspects of design verification and validation and transfer of development projects to production. 

A Sr. Product Development Engineer at Tandem also: 

• Contributes to the design & development of mechanical components and systems for the Company’s medical devices.
• Find and manage vendors for specialized components for use in medical devices
• Performs competitive product analysis and contributes to the development of product requirements.
• Conducts mechanical design of medical devices and fixtures using SolidWorks.
• Builds and assesses mechanical designs using rapid prototyping technologies.
• Manages design verification and validation planning including build plans, traceability documentation, test protocols, test reports, etc.
• Writes detailed and easily understood work instructions, test protocols, and test reports.
• Develops test methods and performs design verification testing.
• Utilizes root cause investigation methodologies to de-bug and solve design performance challenges.
• Performs tolerance analysis of parts and mechanical designs.
• Leads technical review of design requirements, data, design, and verification/validation reports
• Takes part in assessing vendor capabilities.
• Supports transfer of design to production.
• Leads development and implementation of design solutions needed on existing products to meet business needs
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Supports the short-term planning for the department including headcount, budgeting, training, and systems requirements.
• Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
• Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
• Develops and manages schedules and performance requirements of staff.

WHAT YOU’LL NEED:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering or equivalent combination of education and applicable job experience.
• 5 years of medical device product development experience.
• Demonstrated proficiency in mechanical design and development of medical devices.
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
• Proficient with SolidWorks software.
• Familiar with testing methodology and data collection in a development environment.