Manufacturing Engineer II

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: Provides sustaining engineering and equipment support for commercialized medical device products, ensuring stable manufacturing performance, high product quality, and regulatory compliance. Troubleshoots manufacturing issues, leads root cause investigations, and drives continuous improvement initiatives with minimal oversight. Participates in manufacturing development planning and execution for prototype, pilot, and production design transfer. Manufacturing Engineer II’s are also responsible for: Independently troubleshoot manufacturing, process, and equipment issues impacting yield, quality, or throughput. Lead root cause investigations (RCA) and implement effective actions using structured problem‑solving methodologies (5 Whys, Fishbone, DOE) for complex electro‑mechanical failures involving mechanical components, electrical systems, and integrated assemblies. Analyze manufacturing performance data (yield, scrap, downtime) and lead continuous improvement initiatives for electro‑mechanical assembly processes. Evaluate, procure, and support manufacturing equipment. Develop and Execute IQ/OQ/PQ validations. Manage engineering changes (ECOs) to update and maintain manufacturing documentation (DMR and DHR) and bill of materials (BOM). Ensure compliance with FDA QSR and ISO 13485. Support supplier and lifecycle management activities for electro‑mechanical components, including PCBs, cables, batteries and mechanical subassemblies. Participates in continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to improve yield, optimize process efficiency, reduce costs and lead‑times. Develop and deliver training to manufacturing personnel on electro‑mechanical assembly processes, test procedures, and equipment operation. Supports R&D to aid in the transition of new products and processes to manufacturing. Collaborate with Quality to support nonconformances, CAPAs, audits, and regulatory inspections. Partner with Supply Chain to resolve supplier‑related issues, support material changes, and improve incoming quality. Evaluate and implement design or process changes to address field issues, complaints, or obsolescence. Support complaint investigations and failure analysis, including electrical testing, mechanical teardown, and system‑level diagnostics. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements. Other responsibilities as assigned. WHEN & WHERE YOU’LL WORK: Onsite This position is open to candidates in San Diego, California and will work onsite at our manufacturing facility. Equipment for the role will be provided, and training will occur onsite. Schedule: This position will work Monday - Friday from 8:00 AM - 5:00 PM PST. WHAT YOU’LL NEED: Knowledge, skills & abilities: Awareness of federal and other regulations, e.g. QSRs, ISO 14971 IEC 60601 series. Knowledge of Good Documentation Practices (GDP). Familiar with product specifications, test specifications, process specifications. Some integration experience in a manufacturing environment, to assist with design transfers to manufacturing. Good analytical and organizational skills with the ability to prioritize workload. Skilled at presenting information in a clear, concise manner to all levels within the department. Skilled at contributing on a consistent basis to team initiatives in a thorough and timely manner. Able to react to changing situations in a timely, calm, and confident manner. Root cause analysis and problem‑solving skills. Experience with validation and change control. Familiarity with manufacturing equipment systems. SolidWorks or Pro/E (3D modeling knowledge). Basic knowledge of DFM. Working knowledge of Product Lifecycle Management (PLM) system. Minimum certifications/educational level: B.S. degree in Engineering (Mechanical, Biomedical, Electrical) or a related field, or equivalent combination education and applicable job experience. Minimum experience: 3 years of experience in medical device manufacturing. Lean Manufacturing Experience, preferred. Green or Black belt certification, preferred. Design of Experiment and Statistical Analysis, preferred. Experience in process development, preferred. Semi‑automation experience with embedded software, preferred. Agile PLM Software, preferred. ERP/MES experience, preferred. COMPENSATION & BENEFITS: The starting base pay range for this position is $85,000 to $102,000 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 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-HJ1 #LI-Onsite #J-18808-Ljbffr