Sr. Product Development Engineer I at Tandem Diabetes Care in San Diego, CA
Job details Description GROW WITH US:
Headquartered in San Diego with customers all over the world, Tandem Diabetes Care is dedicated to making the lives of people with diabetes better and better through relentless innovation. In Tandem means together, and we strive to embody that in every aspect of our business. Our offices are centrally located north of Downtown with easy access to the freeway. DIABETES IS ALL WE DO:
A DAY IN THE LIFE:
As a member of the product development team, the Sr. Mechanical Engineer will take on a lead role in the design and development of the Company's next-generation disposable medical devices, accessories, and associated test and assembly fixtures. YOU'RE AWESOME AT:
Leads the design, development and verification of mechanical components, mechanisms and systems for the Company's disposable medical devices and accessories. Utilize rapid prototyping technologies for rapid design feedback and iteration. Performs competitive product analysis and contributes to the development of product requirements. Research applicable patents and collaborate with the intellectual property team to assess intellectual property constraints for freedom to operate. Research and review applicable standards and regulatory guidance documents related to products in development. Performs tolerance analysis of parts and assemblies. Responsible for characterizing, specifying, and testing component materials and medical adhesives. Selects components and equipment based on analysis of requirements as well as component specifications and reliability. Assists the Regulatory team in preparing regulatory submissions and supporting them while the product is under review. Assist with sustaining engineering and supporting design changes of existing products. Participates in evaluating the reliability of materials, properties and techniques used in production. Troubleshoots product design and assembly tooling and processes. Works closely with the Quality Engineering team to develop and update Risk Assessments. Develops and delivers training for other engineers, technicians, and operators. Confirms completion of 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. EXTRA AWESOME:
Demonstrated proficiency in designing injection molded parts and assemblies and creating appropriate design documentation. Collaboration with suppliers in design for manufacturability and for custom tooling and automation. Demonstrated proficiency in process development for bonding materials and components. Has a strong understanding of tying product requirements to the design. Demonstrated proficiency in writing test methods, protocols, and reports. Ability to lead a team to integrate information from many sources across the business in order to drive decisions for product development. Exhibits a breadth of technical skills that are applied in several areas. Ability to communicate technical knowledge to varying levels within organization. Proficient with SolidWorks software, PDM, and analysis tools. Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP). Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information. Excellent written communication skills. Capable of using statistical techniques and tools to summarize data and support conclusions. Able to work effectively in a team environment at all levels within the organization. Able to alter behavior and opinions considering new information. Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field 5 years of experience in the medical device field including detailed design, design testing, test documentation, and prototype fabrication of high-volume disposable biomedical devices.
Salary Range:
$80K -- $100K
Minimum Qualification
Mechanical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Headquartered in San Diego with customers all over the world, Tandem Diabetes Care is dedicated to making the lives of people with diabetes better and better through relentless innovation. In Tandem means together, and we strive to embody that in every aspect of our business. Our offices are centrally located north of Downtown with easy access to the freeway. DIABETES IS ALL WE DO:
A DAY IN THE LIFE:
As a member of the product development team, the Sr. Mechanical Engineer will take on a lead role in the design and development of the Company's next-generation disposable medical devices, accessories, and associated test and assembly fixtures. YOU'RE AWESOME AT:
Leads the design, development and verification of mechanical components, mechanisms and systems for the Company's disposable medical devices and accessories. Utilize rapid prototyping technologies for rapid design feedback and iteration. Performs competitive product analysis and contributes to the development of product requirements. Research applicable patents and collaborate with the intellectual property team to assess intellectual property constraints for freedom to operate. Research and review applicable standards and regulatory guidance documents related to products in development. Performs tolerance analysis of parts and assemblies. Responsible for characterizing, specifying, and testing component materials and medical adhesives. Selects components and equipment based on analysis of requirements as well as component specifications and reliability. Assists the Regulatory team in preparing regulatory submissions and supporting them while the product is under review. Assist with sustaining engineering and supporting design changes of existing products. Participates in evaluating the reliability of materials, properties and techniques used in production. Troubleshoots product design and assembly tooling and processes. Works closely with the Quality Engineering team to develop and update Risk Assessments. Develops and delivers training for other engineers, technicians, and operators. Confirms completion of 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. EXTRA AWESOME:
Demonstrated proficiency in designing injection molded parts and assemblies and creating appropriate design documentation. Collaboration with suppliers in design for manufacturability and for custom tooling and automation. Demonstrated proficiency in process development for bonding materials and components. Has a strong understanding of tying product requirements to the design. Demonstrated proficiency in writing test methods, protocols, and reports. Ability to lead a team to integrate information from many sources across the business in order to drive decisions for product development. Exhibits a breadth of technical skills that are applied in several areas. Ability to communicate technical knowledge to varying levels within organization. Proficient with SolidWorks software, PDM, and analysis tools. Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP). Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information. Excellent written communication skills. Capable of using statistical techniques and tools to summarize data and support conclusions. Able to work effectively in a team environment at all levels within the organization. Able to alter behavior and opinions considering new information. Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field 5 years of experience in the medical device field including detailed design, design testing, test documentation, and prototype fabrication of high-volume disposable biomedical devices.
Salary Range:
$80K -- $100K
Minimum Qualification
Mechanical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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