Manager, Manufacturing Engineering

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 leadership and direction for Manufacturing Engineering. Responsible for all aspects of manufacturing engineering of infusion sets. Contributes to both sustaining and new development efforts, including all aspects of new product introduction. Responsible for manufacturing development planning and execution for prototype, pilot, and production design transfer. Responsible for defining, managing, and reducing product costs throughout the life cycle of the product. Supervises a team of engineers and technicians in support of supplier, process, process automation, failure analysis, and manufacturing engineering. Manager, Manufacturing Engineering's at Tandem are also responsible for: Develops and defines automated and manual assembly techniques, tooling, and contributes to electro/mechanical testing development to improve product manufacturability. Directs troubleshooting on systems that either cause or potentially cause work stoppage and reduced throughput times. Designs and/or debugs manufacturing test fixtures for subassemblies and trains manufacturing staff on use. Supports operations with the creation of BOMs, DMRs, DHFs, (e)DHRs, work orders, work instructions, test methods, product costs, and metrics: Creates and measures applicable Metrics, such as cost, schedule adherence, yield, 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 equipment and process requirements and/or validation protocols/reports. Responsible for DOE, 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. Works with the Quality and R&D groups, determines root cause through failure investigation, and develops and implements corrective and preventive action, as required. Tools include PFMECA, FMECA, DOE, Fault Tree analysis. Works closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing: Helps develop production test plans, requirements and specifications. Assists Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities. Works closely with Contract Manufacturer(s) to aid in: Transition of new or existing processes/products. Sustained production of new or existing processes/products. Analyzes and assesses vendor capability to support development and/or high-volume manufacturing. Participates in the selection, development, performance appraisal, merit recommendation, and promotion of department staff. WHEN & WHERE YOU’LL WORK: Hybrid: This role will be a mix of in-office work at our Barnes facility in San Diego, CA Or Irvine, CA location and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands. WHAT YOU’LL NEED: Solid knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs). Proficient with MS Office and knowledgeable of Solidworks software. Ability to effectively use Microsoft Word, Excel, and PowerPoint for effective management reporting and presentation. 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. Excellent skills in cGMP documentation, writing policies and procedures, protocols, work instructions, inspection requirements, etc. Capable of managing multiple priorities effectively and be able to identify and recommend best course of action from several alternatives. Ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship. Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others. Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs. EXTRA AWESOME: B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience. 8 years experience in medical device manufacturing. 3 years experience managing/leading manufacturing engineering staff. Experience in an FDA/GMP/ISO environment. Lean Manufacturing and 6 sigma experience. Project Management experience. COMPENSATION & BENEFITS: The starting base pay range for this position is $142,000 - $177,000 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-KT1 #LI-Hybrid Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California.