Senior Test Engineer

MiniMed • Los Angeles, CA

1d • $97,000 - $165,000

About The Position

The Senior Test Engineer leads the design, development, validation, and sustaining of automated test equipment (ATE) and manufacturing test systems for complex medical devices. The role ensures manufactured products meet quality, performance, and regulatory standards. As a technical subject matter expert, the engineer advances test strategies and collaborates with R&D, Manufacturing, Quality, and other teams to deliver test solutions.

The position covers test-system architecture, hardware and software development, test strategy, equipment qualification and validation, regulatory compliance, and production support. It also provides technical leadership and mentorship, supports New Product Introduction (NPI), and drives automation, digitalization, cost reduction, and continuous improvement across manufacturing test capabilities.

Requirements

• Bachelor's degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
• Strong expertise in test-system architecture, hardware design, software development, and validation methodologies.
• Understanding of regulatory requirements governing medical-device manufacturing.
• Ability to lead complex technical projects from concept through production deployment.
• Strong project management skills, including managing multiple concurrent programs.
• Excellent analytical and problem-solving skills and a data-driven approach.
• Outstanding written and verbal communication skills, including presenting to senior leadership.
• Ability to mentor and develop junior engineering talent.
• Strong cross-functional collaboration across R&D, Quality, Manufacturing, and Regulatory teams.
• Ability to influence without authority in a matrixed organization.

Nice To Haves

• 8–12+ years of progressive experience in manufacturing test equipment design and development.
• At least 5 years of experience in a regulated medical-device, aerospace, or defense manufacturing environment.
• Experience leading test equipment design from concept through validation in a regulated environment.
• Expertise in test fixture and hardware design, analog and digital circuit design, LabVIEW/TestStand development, and Python, C#, or C++ programming.
• Experience with IQ/OQ/PQ equipment validation, FDA 21 CFR Part 820, ISO 13485, 21 CFR Part 11, Gauge R&R, measurement systems analysis, and ISO 14971 risk management.
• Experience integrating COTS instruments, including NI and Keysight equipment, and MES/ERP systems.
• Experience with PCB design tools such as Altium or Cadence, Six Sigma or Lean Manufacturing, and machine vision systems.
• Master's degree in Electrical Engineering, Computer Engineering, or a related field.
• NI Certified LabVIEW Architect or NI Certified TestStand Developer certification.
• Six Sigma Green Belt or Black Belt certification.
• PMP certification.
• Experience with implantable or active medical devices, such as insulin pumps, cardiac devices, or neurostimulators.
• Knowledge of RF and wireless testing methodologies, including Bluetooth, NFC, or ANT+.
• Experience with machine vision for automated visual inspection.
• Familiarity with Industry 4.0 or IoT integration in manufacturing test environments.
• Experience with environmental stress screening and highly accelerated life testing (HALT/HASS).
• Background in ESD control and testing.
• Knowledge of IPC-A-610 and PCB assembly inspection standards.
• Experience supporting FDA inspections or Notified Body audits.

Responsibilities

• Lead architecture, design, and development of automated test equipment, functional test systems, and manufacturing test fixtures for medical devices and subassemblies.
• Design hardware test systems, including custom PCBs, test fixtures, bed-of-nails fixtures, and electrical interface assemblies.
• Develop test software and firmware for automated test execution, data acquisition, and result reporting.
• Design analog and digital signal-conditioning circuits for precision measurement of device-under-test parameters.
• Develop test systems that evaluate electrical, functional, mechanical, and environmental performance.
• Create and maintain test equipment documentation, including schematics, bills of materials, software architecture documents, and user manuals.
• Evaluate and select commercial off-the-shelf test instruments and integrate them into custom solutions.
• Define test strategies for new products and manufacturing processes, test coverage matrices, acceptance criteria, and test-escape risk mitigation strategies.
• Collaborate with R&D and Design Engineering to influence Design for Testability early in product development.
• Lead test equipment qualification and validation activities, including IQ/OQ/PQ, and conduct Gauge R&R studies.
• Develop automated test software, test executive frameworks, operator-facing interfaces, data logging, pass/fail reporting, and database integrations.
• Maintain software version control and documentation practices in accordance with 21 CFR Part 11; integrate test systems with MES and ERP platforms.
• Ensure test equipment and software comply with applicable FDA, ISO, and other regulatory requirements; maintain measurement uncertainty analyses and calibration programs traceable to national standards.
• Support regulatory submissions and provide test equipment documentation for FDA and Notified Body reviews.
• Participate in ISO 14971 risk management activities related to test equipment failures and test escapes.
• Serve as primary test engineering lead for NPI programs; plan equipment projects, manage timelines, and communicate status to program leadership.
• Support pilot builds and production ramps by ensuring test equipment readiness and providing operator training.
• Provide sustaining support for test equipment, including troubleshooting, repairs, upgrades, and engineering change orders.
• Analyze test yield and lead improvement initiatives to improve test efficiency and reduce escapes.
• Serve as a technical subject matter expert, mentor engineers and technicians, lead design reviews, develop training, and represent test engineering in program teams and leadership presentations.
• Champion automation and digitalization; drive cost reduction, test optimization, cycle-time reduction, equipment standardization, predictive maintenance, and continuous improvement events.
• Develop and track test equipment performance KPIs, including uptime, test cycle time, and first-pass yield.

Benefits

• Competitive salary and flexible benefits package.
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account access.
• Healthcare Flexible Spending Account access.
• Life insurance.
• Long-term disability coverage.
• Dependent daycare spending account.
• Incentive plans.
• 401(k) plan with company match.
• Short-term disability coverage.
• Paid time off and holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior