Tandem Diabetes Care
Manager, Electrical Test Engineering
Tandem Diabetes Care, San Diego, California, United States, 92189
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.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 debug manufacturing test fixtures for electro-mechanical and pneumatic subassemblies and train 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.Perform V&V activities and document 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.Work with the Quality and R&D groups to determine root cause through failure investigation, and develop and implement corrective and preventive action, as required.Work closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing.Develop and maintain an electrical design group that supports the company product goals, future and existing.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, conduct experimental tests and evaluate 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.
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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.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 debug manufacturing test fixtures for electro-mechanical and pneumatic subassemblies and train 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.Perform V&V activities and document 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.Work with the Quality and R&D groups to determine root cause through failure investigation, and develop and implement corrective and preventive action, as required.Work closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing.Develop and maintain an electrical design group that supports the company product goals, future and existing.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, conduct experimental tests and evaluate 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.
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