Tandemdiabetes

Tandemdiabetes

Manufacturing Engineer II

California - Barnes · Mid · Contract

No sponsorship$85k-$102kDetected 30 days ago
ReactStatisticsComplianceProduct ManagementSupply ChainProcess ImprovementERPSolidWorksEmbedded SystemsHIPAAFDA RegulatoryMedical DevicesProblem SolvingPublic SpeakingOrganizational SkillsLean Manufacturing

About the role

  • 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.
  • 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.

Responsibilities

  • Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin.
  • 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.
  • 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)
  • 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.

Requirements

  • Knowledge, skills & abilities:
  • 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.
  • 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.

Nice to have

  • Lean Manufacturing Experience, preferred.
  • Green or Black belt certification, preferred.
  • Experience in process development, preferred.
  • Semi-automation experience with embedded software, preferred.
  • Agile PLM Software, preferred.
  • ERP/MES experience, preferred.

Skills

  • 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.
  • 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.
  • 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

Compensation

  • 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.
  • 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.

Benefits

  • 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!
  • Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience.

Company info

  • 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.
  • We love a good referral!

Equal opportunity

  • 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.

Visa & Work Authorization

  • 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.
Apply directly at Tandemdiabetes →Create a free account for alerts like thisView Tandemdiabetes immigration profile

This listing is sourced directly from Tandemdiabetes's careers page and normalized into a canonical job model.