San Diego, California, USA
7 days ago
Sr. Medical Device Engineer I (Electro-Mechanical) 3x openings

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 Senior Product Development Engineer I will take on a lead role in the design and development of the Company’s next-generation medical devices, accessories, test and assembly fixtures, and data collection systems.

Develops the Company’s next-generation medical devices and accessories. Creates subsystem requirements, architecture, and engineering specifications. Mechanical design of product and fixture assemblies, parts, and drawings using SolidWorks. Builds and assesses mechanical designs using rapid prototyping technologies. Performs competitive product analysis and contributes to the development of product requirements. Creates engineering drawings in accordance with ASME Y14.5 GD&T standard. Conducts tolerance stack-up analysis for both parts and assemblies. Drafts and executes both test method validation and design verification testing. Writes detailed technical reports summarizing test results and experimental design. Troubleshoots product design and assembly tooling and processes. Responsible for characterizing, specifying, and testing component materials. 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. 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. Other responsibilities as assigned.

YOU’RE AWESOME AT:

5 years of product development experience in the medical device field including detailed design, design testing, test documentation, and prototype fabrication of medical devices. Bachelor’s degree in mechanical engineering, biomedical engineering or related field or equivalent combination of education and applicable job experience. Previous experience designing small, complex parts and assemblies using SolidWorks. Demonstrated proficiency in designing injection molded parts and assemblies Exposure to testing methodology and data collection in a development environment. Experience using electronics test equipment such as oscilloscope, logic analyzer and DMM. Proven ability to set up a bench test to collect some data (both HW and SW development). Ability to analyze data with statistical reasoning using Python and Excel. Ability to program in Python for hardware test development. Experience in specifying and analyzing part and assembly tolerances Demonstrated proficiency in writing test methods, protocols, and reports. Ability to clearly communicate ideas and persuade others through consolidating, evaluating, and presenting relevant information. Excellent written and verbal communication skills. Strong understanding of statistics and tools to summarize data and support conclusions. Ability to work effectively in a team environment at all levels within the organization. Working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series. Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP). Proficient with SolidWorks software, PDM, and analysis tools.

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 $105,400 - $130,000 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.

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