R&D Lab Supervisor

Manage daily operations of the R&D laboratory, ensuring a safe, organized, and efficient work environment Develop and maintain laboratory procedures, work instructions, and testing protocols Oversee laboratory scheduling, equipment utilization, and resource allocation Ensure laboratory compliance with applicable safety, quality, and regulatory requirements Establish and monitor laboratory performance metrics and continuous improvement initiatives Research & Development Support Partner with Engineering, Quality, Regulatory Affairs, Manufacturing, and Product Development teams to support product development activities Oversee execution of feasibility, design verification, validation, and characterization testing Review and approve test plans, protocols, reports, and technical documentation Support root cause investigations, failure analysis, and product improvement efforts Evaluate and implement new technologies, testing methods, and laboratory capabilities Foster a culture of innovation, accountability, collaboration, and continuous improvement Ensure staff are trained on laboratory procedures, equipment operation, safety requirements, and quality system processes Quality and Regulatory Compliance Maintain compliance with Quality Management System (QMS) requirements, including FDA 21 CFR Part 820, ISO 13485, and applicable international regulations Ensure proper documentation practices in accordance with Design Control and Good Documentation Practices (GDP) Support internal audits, external audits, and regulatory inspections. Ensure traceability and integrity of laboratory data and records. Equipment and Facility Management Manage laboratory equipment qualification, calibration, maintenance, and replacement programs. Develop annual laboratory budgets and capital equipment plans. Evaluate and procure laboratory instrumentation, testing systems, and supplies. Coordinate laboratory expansions, upgrades, and infrastructure improvements as needed. Project Management Support multiple concurrent R&D projects while maintaining timelines and resource availability. Collaborate with project teams to establish testing strategies and development plans. Provide regular updates on laboratory activities, project status, risks, and resource needs. Drive laboratory efficiency improvements to support accelerated product development. Required Qualifications Minimum 5 years of experience in medical device R&D, laboratory operations, product development, or testing environments. Experience working within FDA-regulated and ISO 13485-certified environments. Strong understanding of Design Controls, verification and validation testing, and product development processes Demonstrated project management and cross-functional leadership skills. Excellent written, verbal, and technical communication skills. Preferred Qualifications Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Materials Science, Chemistry, Biology, or related scientific discipline Experience with Class II and/or Class III medical devices Knowledge of risk management methodologies including ISO 14971 Experience supporting regulatory submissions and design history file documentation Certification in Project Management (PMP) or Quality Engineering (CQE) preferred Experience implementing laboratory information management systems (LIMS) or electronic laboratory documentation systems #J-18808-Ljbffr Lumicity