R&D Test Lab Lead

5 hours ago

Montreal, Canada Boston Scientific Full time

Role Overview Boston Scientific is hiring a Test Lab Lead to coordinate and oversee laboratory operations that support the verification of medical devices. The Test Lab Lead ensures compliance with stringent regulatory standards, manages test environments, and maintains specialized equipment used for design verification activities. Working closely with engineering and quality teams, the Test Lab Lead ensures that all devices meet safety, performance, and reliability requirements before clinical or commercial release. Responsibilities Oversee day‑to‑day laboratory activities to ensure smooth and efficient operations. Manage inventory of test fixtures, measurement instruments, and consumables. Enforce electrical safety and ESD protocols during all testing activities. Develop and enforce laboratory protocols, workflows, and SOPs. Conduct regular safety audits and provide safety training for laboratory staff. Supervise and mentor lab technicians, providing guidance on testing practices and equipment usage. Foster effective collaboration between design engineering and verification teams. Partner with Quality to coordinate calibration and preventive maintenance of laboratory test equipment. Maintain accurate records of equipment usage, calibration status, and service history. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Minimum Qualifications Bachelor’s or master’s degree in biomedical engineering, electrical engineering, or a related technical field. Strong understanding of medical device verification methodologies and regulatory requirements. Strong organizational, leadership, and laboratory coordination skills. Excellent communication and problem‑solving abilities. Preferred Qualifications Technical knowledge of testing concepts for electrical and electro‑mechanical equipment. Knowledge of ISO 13485, IEC 60601, and FDA design control standards. Familiarity with risk management principles per ISO 14971. Hands‑on experience with electrical safety testing and biocompatibility testing. Language and Communication Effective communication in English, and in some duties knowledge of French (oral and written) is also required. English is the primary language for collaboration with colleagues, clients, and stakeholders across Canada, the United States, and internationally. Salary Minimum: $79,700; Maximum: $158,200. #J-18808-Ljbffr

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