Principal Test Engineer

About the Role We are seeking a highly skilled and experienced Principal Test Engineer to join our team in the medical device industry. In this role, you will lead the design, development, and deployment of complex test equipment to ensure the highest quality and reliability of our innovative medical devices, collaborating with cross-functional teams including R&D, manufacturing, and quality assurance. Responsibilities Lead the design and development of complex automated and manual test equipment for medical devices, ensuring compliance with industry standards and internal requirements. Define system architecture, hardware, and software requirements for test equipment. Develop test methods, protocols, and procedures to validate product functionality, performance, and reliability. Manage multiple test equipment development projects from concept to deployment, including timelines, budgets, and resource allocation. Collaborate with cross‑functional teams to align testing strategies with product development goals and manufacturing processes. Oversee the validation and verification of test equipment, including IQ, OQ, and PQ activities, in compliance with FDA, ISO, and other regulatory standards. Ensure all test equipment meets safety and quality requirements before deployment. Lead the deployment of test equipment to manufacturing facilities and provide training to operators and technicians. Troubleshoot and resolve technical issues with test equipment in a timely manner. Identify opportunities for process improvements, cost reductions, and increased efficiency in test equipment design and deployment. Stay up‑to‑date with emerging technologies and industry trends to drive innovation in test methodologies. Develop and maintain detailed documentation, including design specifications, test plans, and validation reports. Ensure compliance with all applicable regulatory standards, such as FDA, ISO 13485, and IEC 60601. Mentor and guide junior engineers and technicians, fostering a culture of technical excellence and continuous learning. Act as a technical expert and provide guidance on complex engineering challenges. Minimum Qualifications Bachelor’s degree and minimum of 7 years of relevant experience, or Master’s degree with a minimum of 5 years relevant experience, or PhD with at least 3 years relevant experience. Preferred Qualifications Proficiency in hardware and software development for test systems (LabVIEW, Python, C++, or similar). Proficiency in PCBA design and fabrication (Altium Designer). Strong knowledge of data acquisition systems, sensors, actuators, and control systems. Experience with automated test equipment (ATE) and robotics. Regulatory Knowledge Familiarity with FDA, ISO 13485, IEC 60601, and other relevant medical device standards. Experience with risk management and Design for Testability (DFT) principles. Soft Skills Strong problem‑solving, analytical, and critical‑thinking skills. Excellent communication and interpersonal skills to work effectively with cross‑functional teams. Physical Job Requirements The role requires independent mobility and interaction with a computer. Reasonable accommodations may be made for individuals with disabilities. Benefits & Compensation Salary ranges for U.S. (excluding PR) locations: USD 109,000 – 185,000. In California, Seattle, Washington DC, Boston, and New York City, the range is USD 121,000 – 205,000. Compensation may vary based on experience, education, certifications, skills, market conditions, and geographic location. Eligible for a short‑term incentive (STI). Benefits include health, dental, and vision insurance; access to a Health Savings Account (HSA); Healthcare Flexible Spending Account; life insurance; long‑term disability; paid time off; holidays; 401(k) plan with company match; Employee Stock Purchase Plan; and Employee Assistance Program. EEO Statement MiniMed is an equal employment opportunity employer. We provide non‑discriminatory employment opportunities and reasonable accommodations for qualified individuals with disabilities in accordance with federal, state, and local laws. #J-18808-Ljbffr