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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 the "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 Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're 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. Because many of our own team members live with 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: The Systems Engineer II is a key team member responsible for providing advanced technical contributions to the documentation, testing, analysis, troubleshooting, and debugging of the Company's medical device systems. This role plays a critical part in ensuring system reliability, compliance, and performance by executing test plans, identifying issues, and collaborating with cross-functional teams to drive solutions. The Systems Test Engineer II also contributes to process improvements, test automation, and validation efforts to enhance overall product quality and efficiency.
Systems Engineer II's at Tandem are also responsible for:
- Works within design controls and contributes to the design history file for medical devices by verifying product performance through formal test methods, protocols, and reports.
- Evaluates development plans and design changes to components, assessing their impact on integrated systems testing and test equipment.
- Leads and participates in the verification of prototype components and systems, ensuring alignment with design requirements.
- Designs and executes experiments, analyzes and interprets data, and reports findings with clear conclusions and recommendations.
- Develops and validates test methods, including performance verification through Gage R&R studies.
- Participates in comprehensive reviews of requirements, designs, data, and design verification protocols/reports to ensure system integrity.
- Recommends and selects test equipment based on thorough analysis of requirements and component specifications.
- Contributes to the evaluation of material, component, and system reliability to enhance product performance and durability.
- Supports systems engineering testing and troubleshooting for both new and existing products, driving improvements and issue resolution.
- Develops, manages, and oversees development and testing activities at external test facilities and vendors.
- Actively participates in product and process risk assessments, identifying and implementing mitigations to enhance safety and compliance.
- Completes all required training plans before assuming full job responsibilities, ensuring adherence to regulatory and company standards.
WHEN & WHERE YOU'LL WORK: This role is on-site five days a week at our Del Mar Headquarters due to the nature of the work involved. This position has a schedule of Mon.- Fri. 8:00 am - 5:00 pm PT. WHAT YOU'LL NEED:
- Bachelor's degree in mechanical engineering, electrical engineering, biomedical engineering, computer engineering or related field or equivalent combination of education and applicable job experience.
- 2+ years of experience in systems testing, verification, or a related technical role, preferably in the medical device industry or other regulated environments.
- Strong ability to communicate technical knowledge effectively to varying levels within the organization.
- Experience with testing methodologies and data collection in a development environment is highly valuable.
- Skilled at asserting ideas and influencing others by effectively consolidating, evaluating, and presenting relevant technical information.
- Excellent written communication skills with proficiency in MS Office for documentation and reporting.
- Capable of applying statistical techniques and tools to analyze data, summarize findings, and support conclusions.
- Proven ability to collaborate effectively in a team environment across all levels of the organization.
- Adaptable and open to modifying approaches and opinions based on new information and insights.
- Working knowledge of federal and industry regulations, including QSRs, ISO 14971, and IEC 60601 series, ensuring compliance in testing and documentation.
- Proficient in Good Documentation Practices (GDP) to maintain accuracy and regulatory compliance.
- Ability to use SolidWorks to create and modify engineering models and drawings as needed for testing and verification purposes.
COMPENSATION & BENEFITS: The starting base pay range for this position is $$87,300-$109,000 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! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment 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 information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. 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. 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. WHY YOU'LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers. BE YOU, WITH US! We embrace the value that every single one of us brings 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. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! 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. #LI-Onsite #LI-BC1
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