Manager, Electrical Test Engineering

Tandem Diabetes Care•Ruth, CA

1d•$142,000 - $177,000•Onsite

About The Position

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. 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. 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. Leads the Automated Test Engineering function, overseeing the design, development, validation, and deployment of test systems for electromechanical insulin pump devices. This role is responsible for managing and developing a high-performing team while driving test engineering strategies that support both new product development and sustaining activities. The position ensures effective execution of test development across prototype, pilot, and production phases, including design transfer. It also drives cost optimization throughout the product lifecycle and supports cross-functional initiatives spanning suppliers, manufacturing processes, automation, failure analysis, and quality.

Requirements

Strong knowledge of FDA QSR, GMP, ISO and IEC standards.
Expertise in test engineering, product specifications, and manufacturing processes.
Proven ability to drive quality, reliability, and cost improvements.
Strong documentation and technical writing skills (protocols, procedures, work instructions).
Demonstrated leadership, problem-solving, and project management capabilities.
Ability to manage multiple priorities and influence cross-functional stakeholders.
Proficiency in Microsoft Office tools.
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 from 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.

Nice To Haves

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 medical device designing and developing test fixtures to support medium to high volume manufacturing.
6+ years leading technical teams
Hands-on experience with Lean Manufacturing and Six Sigma methodologies.
Proven project management experience.
5 years prior experience leading/supervising a customer facing department and associated staff is preferred.
Experience in a high volume, medical device, biotech, or pharmaceutical environment preferred.

Responsibilities

Lead, mentor, and develop a team of test and manufacturing engineers.
Drive team performance, training plans, and career development.
Partner cross-functionally with R&D, Quality, Manufacturing, and Supply Chain.
Support workforce planning, budgeting, and goal setting.
Provide subject matter expertise in electronic systems, components, and test methodologies.
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.
Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
Develops and manages schedules and performance requirements of staff.
Define and execute test strategies for prototype, pilot, and production phases.
Design, develop, and troubleshoot automated and manual test systems and fixtures for electromechanical and pneumatic assemblies.
Establish test requirements, specifications, and production test plans.
Support new product introduction (NPI) and design transfer into manufacturing.
Develop assembly processes, tooling, and test methodologies to improve manufacturability and throughput.
Lead troubleshooting of mechanical, electrical, disposable, and pneumatic systems impacting production.
Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, and Kaizen methodologies.
Evaluate and select components, materials, and equipment based on reliability and performance.
Analyze vendor capabilities and support supplier development.
Develop and execute verification and validation (V&V) activities, including IQ/OQ/PQ protocols.
Ensure compliance with FDA, GMP, ISO, and company quality systems.
Support supplier qualification and validation of external test processes and equipment.
Oversee development of BOMs, work instructions, change orders, and design documentation.
Track and report key performance metrics (yield, cost, cycle time, schedule adherence).
Maintain accurate and compliant design history files (DHF) and technical documentation.
Lead root cause investigations and corrective/preventive actions (CAPA).
Utilize tools such as FMEA/PFMECA, DOE, and fault tree analysis.
Drive product and process improvements to enhance reliability and cost performance.