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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since many of our own team members live with type 1 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:
Standard working hours: M-F, 9-5p PST
Position will be held onsite (High Bluff HQ)
As a member of the product development team, the Sr. Medical Device Engineer (Electro-Mechanical) II will take on a lead role in the design and development of the Company’s next-generation medical devices, accessories, and associated test and assembly fixtures. This team member is expected to be a leading contributor 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.
Leads the design and development of electro-mechanical components and systems for the Company’s 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 execution and documentation of design verification and validation testing. Leads others through the process of design, development, and verification of mechanical systems. Writes detailed and easily understood work instructions, test protocols, and test reports. Develops design verification test methods. 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. Designs components for reliability/robustness. Responsible for characterizing, specifying, and testing component materials. Research applicable patents and collaborates with the intellectual property team to assess intellectual property constraints for freedom to operate. Research and reviews applicable standards and regulatory guidance documents related to products in development. Assists the Regulatory team in preparing regulatory submissions and supporting them while the product is under review. Works closely with the Quality Engineering team to develop and update Risk Assessments. 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. Independently plans and manages tasks and design and development projects. Represents the development team in cross functional team meetings and provides project updates. Confirms completion of required training plan before assuming job responsibilities. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements. Other responsibilities as assigned.YOU’RE AWESOME AT:
8 plus years of medical device product development including detailed design, design testing, test documentation, and prototype fabrication of medical devices. Bachelor's degree in Mechanical Engineering, Biomedical Engineering or equivalent combination of education and applicable job experience. Demonstrated proficiency in mechanical design and development of medical devices. Skilled at leading team through design and development process. Proficient with SolidWorks PDM, and analysis tools. Experience in material selection for polymers and metals. Familiar with testing methodology and data collection in a development environment. Python experience in hardware development valuable. Ability to collaborate with suppliers in design for manufacturability and for tooling and automation. Experience in material selection for polymers and metals. Demonstrated proficiency in injection molded part design and managing mold tooling development. Experience with transfer of design to manufacturing and sustaining engineering valuable. Proficient in determining part tolerances and analyzing tolerances of assemblies and processes. Experience in vendor and project management. Strong understanding of tying product requirements to the design. Demonstrated proficiency in writing test methods, protocols, and reports. Ability to communicate technical knowledge to varying levels within organization. Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP). Excellent oral and written communication skills. Capable of using statistical techniques and tools to summarize data and support conclusions. Ability to work effectively in a team environment at all levels within the organization. Experience with MS Office.WHAT’S IN IT FOR YOU?
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $126,200 - $158,000 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, equity, and a robust benefits package.
Tandem offers health care benefits such as medical, dental, vision, 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 (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!
YOU SHOULD KNOW:
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and other similar, applicable state and local laws. A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information.
Tandem has good cause to conduct a review of criminal history for this position as this position will have access to customer’s protected health information and regular contact with customers. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.
REFERRALS:
We love a good referral! If you know someone that would be a great fit for this position, please share!
If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.
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.
#LI-Onsite #LI-KL1
SPONSORSHIP:
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.