Product Development Engineer II

About the position

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. The Product Development Engineer II position at Tandem is responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of the Company's products, test and assembly fixtures, and data collection systems.

Responsibilities

• Participates in the research and development of components and systems for the Company's products, utilizing knowledge of engineering theory and materials or component properties.
• Conducts mechanical design of the products and fixtures using SolidWorks.
• Builds and assesses mechanical designs using rapid prototyping technologies.
• Supports design and implementation of changes to existing products.
• Manages execution and documentation of design verification and validation testing.
• Writes detailed and easily understood work instructions, test protocols, and test reports.
• Utilizes root cause investigation methodologies to de-bug and solve design non-conformances.
• Performs tolerance analysis of parts and assemblies.
• Utilizes statistical analysis to understand and define process capabilities.
• Plans, designs, develops, modifies, and evaluates fixtures, equipment, and assembly processes.
• Drives the design, development, and qualification of medical device pilot assembly line.
• Designs and runs experiments, analyzes, and summarizes data, and reports the 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.
• Creates documentation required for qualification and operation of pilot assembly line.
• Participates in evaluating the reliability of materials, components, and systems.
• Performs and interprets troubleshooting of assembly process issues.
• Develops and manages development and testing at external test facilities/vendors.
• Reviews and assesses vendor capability to support development.
• Completes 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.

Requirements

• 2 years of product development experience in the medical device field.
• Bachelor's degree in mechanical engineering, biomedical engineering or related field or equivalent combination of education and applicable job experience.
• Strong understanding of mechanical engineering principles including materials, fasteners, fits/tolerances, heat transfer, and stress/strain.
• Skilled in SolidWorks for creating and modifying parts, assemblies, and detailed drawings.
• Strong understanding of how to apply the scientific method in an engineering context; root cause analysis is a primary example.
• Capable of applying statistical tools to summarize data, identify trends, and support engineering conclusions.
• Exposure to design verification activities including defining product requirements, developing test methods, conducting tests, and writing reports.
• Experience with programming in Python or C and using tools like Raspberry Pis and Arduinos is preferred.
• Proficient in communicating technical concepts to different audiences with varying levels of technical knowledge and needs.
• Familiar with design controls and regulatory standards such as QSR, ISO 14971, and IEC 60601.
• Knowledgeable in Good Documentation Practices (GDP).

Nice-to-haves

• Experience in product development; experience with medical device design and manufacturing process development is preferred.
• Experience with dimensional tolerance analysis; knowledge of Geometric Dimensioning & Tolerancing (GD&T) and statistical tolerancing is preferred.
• Familiarity with basic electronic components such as capacitors, inductors, resistors, PCBs, and connectors is preferred.

Benefits

• Competitive compensation package including bonus.
• Robust benefits package.