Manager, Electrical Test 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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since many of our own team members live with type 1 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:

An Electrical Test Engineering Manager at Tandem Diabetes Care provides leadership for the Automated Test Engineering team. This role is responsible for all aspects of test engineering of test systems for electromechanical insulin pumps. A highly skilled senior team member responsible for the management, training, and leadership of individuals and teams to design, troubleshoot, document and test electronic components and systems in the Company’s medical devices. This individual contributes to both sustaining and new development efforts, including all aspects of new product introduction. This role is responsible for test development planning and execution for prototype, pilot, and production design transfer and for defining, managing, and reducing product costs throughout the life cycle of the product. This managerial role also supervises a team of engineers in support of supplier, process, process automation, failure analysis, and test engineering. This position will be on-site 5 days a week in our San Diego manufacturing facility.

Electrical Test Engineering Managers at Tandem:

• Develop and define automated and manual assembly techniques, tooling, and contribute to electro/mechanical testing development to improve product manufacturability.
• Direct troubleshooting on disposable, mechanical, electrical and pneumatic systems that either cause or potentially cause work stoppage and reduced throughput times.
  • Design and/or debugs manufacturing test fixtures for electro-mechanical and pneumatic subassemblies and trains manufacturing staff on use.
• Support operations with the creation of BOMs, work instructions, product costs, and metrics:
• Develop and update work instructions and bill of materials.
• Manage and release change orders.
• Create and measure applicable Metrics, such as cost, schedule adherence, yield, etc.
• Responsible for meeting product cost targets and defining and implementing product cost activities.
• Initiate and implement continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
• Participate in Sustaining Engineering activities, including design improvements in support of improved manufacturing and testing of company’s products.
• Develop 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.
• Specify and/or validate test processes and equipment to be used by external suppliers and assist in reviewing Supplier Capability.
• Provide training and leadership to manufacturing personnel on procedure, process, and equipment changes.
• Working with the Quality and R&D groups, determine root cause thru failure investigation, and develop and implement corrective and preventive action, as required.
  • Tools include PFMECA, FMECA, DOE, Fault Tree analysis.
• Work closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing:
  • Help develop production test plans, requirements and specifications.
  • Assist Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities.
• Develop and maintain an electrical design group that supports the company product goals, future and existing.
• Play an active leadership role in the research and development of electronic components and systems for the Company’s medical devices, utilizing advanced knowledge of electronic theory and materials properties.
• Plan, design, develop, modify, and evaluate electronic parts, components, integrated circuitry, mechanical systems, equipment and packaging, optical systems and/or DSP systems.
• Propose varied design approaches and parameters with analyses of each option.
• Analyze equipment to establish operating data, conducts experimental tests and evaluates results.
• Select components and equipment based on analysis of specifications and reliability.
• Analyze and assess vendor capability to support development.
• Evaluate the reliability of materials, properties and techniques used in production.
• Prepare project status reports including milestone dates, product backlog tasks and other aspects of the Design Control process.
• Manage assigned projects to completion.
• Review final project documentation (including Design History Files) for content and accuracy.
• Motivate and manage staff to work closely with production, supply chain, quality, and product development teams.
• Ensure department staff is properly trained, per designated training plan, before assuming job responsibilities.
• Ensure compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Participate in the selection, development, performance appraisal, merit recommendation, and promotion of department staff.
• Support the development, communication, and evaluation of goals for the group on an annual basis.
• Participate in the short and long term planning for the department including headcount, budgeting, training, and systems requirements.

YOU’RE AWESOME AT:

• Solid knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
• Proficient with MS Office.
• 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.
• 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.

YOU'LL NEED:

• B.S. degree in Electrical Engineering or other Engineering or a related field, or equivalent combination of education and applicable job experience.
• 6 years of experience in the field including detailed design, design testing, testing documentation, and prototype fabrication of biomedical devices, including experience with conceptual.
• 6 years’ experience in medical device manufacturing and/or testing engineering.
• Experience in a FDA/GMP/ISO environment.
• Lean Manufacturing and 6 sigma experience.
• Project Management experience.

WHAT’S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $137,000 - $172,000 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, equity, and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision, 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 (starting in year 1) and have access to a 401k plan with company match. 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 thorough 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.

REFERRALS:

We love a good referral! If you know someone that would be a great fit for this position, please share!

If you are applying for this job and live in California, please read Tandem’s CCPA Notice:

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.

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.

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