Tandem Diabetes Care
San Diego, CA
What you’ll be doing:
Provides technical leadership for Cartridge Automation in Manufacturing. Contributes to both sustaining and new development efforts, including all aspects of new product introduction. Aids in manufacturing development planning and execution for prototype, pilot, and production design transfer of automation. Responsible for defining process automation and equipment maintenance and ensuring uptime, cycle time, and safety related to the automation of the Cartridge manufacturing line.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. ‘In Tandem’ means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.
We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: and see what our customers are saying here: #tsliminthewild
What you need for this position:
PRIMARY DUTIES & RESPONSIBILITIES:
- Develops and defines automated and manual assembly techniques, tooling, and contributes to electro/mechanical testing development to improve product manufacturability.
- Responsible for troubleshooting mechanical, electrical and pneumatic systems that either cause or potentially cause work stoppage and reduced throughput times.
- Designs and/or debugs manufacturing test fixtures for electro-mechanical and pneumatic subassemblies and trains manufacturing staff on use.
- Supports operations with the creation of equipment operating procedures, preventative maintenance, Spare Parts program, and budgeting:
- Develops and updates equipment operating instructions and preventative maintenance procedures.
- Manages and releases change orders.
- Creates and measures applicable Metrics, such as cost, schedule adherence, yield, Spare Parts usage, etc.
- Responsible for meeting product cost targets and defining and implementing product cost activities.
- Initiates and implements continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
- Leads teams in the implementation of Lean Manufacturing and 6 sigma techniques.
- Participates in Sustaining Engineering activities, including design improvements in support of improved manufacturing and testing of company’s products.
- Reviews Process Capability Analysis (CPk).
- Develops internal verification requirements and/or validation protocols.
- Performs V & V activities and documents findings as required.
- Responsible for IQ OQ PQs, including writing and executing protocols.
- Specifies and/or validates test processes and equipment to be used by external suppliers and assists in reviewing Supplier Capability.
- Provides training and leadership to manufacturing personnel on procedure, process, and equipment changes.
- Working with the Quality and R & D groups, determines root cause thru failure investigation, and develops and implements corrective and preventive action, as required.
- Tools include PFMECA, DOE, Fault Tree analysis.
- Works closely with R & D and Design Engineering to aid in the transition of new equipment and processes to manufacturing:
- Helps develop equipment solutions, requirements and specifications.
- Assists Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities.
- Ensures technician staff is properly trained, per designated training plan, before assuming job r
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Other duties as assigned.
- Knowledge, skills & abilities:
- Solid knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
- Proficient with MS Office and knowledgeable of Solidworks software.
- Proficient in understanding product specifications, test specifications, process specifications.
- Proven ability to drive quality and productivity improvements.
- Advanced integration experience in a manufacturing environment, to assist with the transfer of testing methodology to manufacturing.
- Capable of managing multiple priorities effectively and be able to identify and recommend best course of action from several alternatives.
- Able to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
- Skilled at creating a team environment that supports a common vision. Proficient at effectively prioritizing goals, assessing team capability, and coordinating resources to achieve those goals.
- Ability to effectively use Microsoft Word, Excel, and PowerPoint for effective management reporting and presentation.
- Minimum certifications/educational level:
- S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
- Minimum experience:
- 4 years experience in medical device manufacturing.
- Experience leading or managing critical projects.
- Experience in a FDA/GMP/ISO environment.
- Lean Manufacturing and 6 sigma experience.
- Project Management experience.
- A seasoned, experienced professional with a full understanding of area of specialization.
- Resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Normally receives little instruction on day-to-day work, general instruction on new assignments.
What’s in it for you?
We’ve got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!
Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.
San Diego, California, United States