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 an Employee Stock Purchase plan. Learn more about Tandem's benefits here!
APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.
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