R&D Lab Supervisor Job Los Angeles area,California USA,Engineering

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

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