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Position Summary

The Lab Operations Lead is responsible for overseeing the daily operations of the laboratory to ensure efficient, compliant, and safe execution of research, development, verification, and testing activities. This role partners closely with Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, and Facilities to maintain laboratory readiness, optimize workflows, and support product development from concept through commercialization. The ideal candidate is a hands-on leader with experience in regulated laboratory environments, preferably within the medical device industry.

Key Responsibilities

Laboratory Operations

• Lead the day-to-day operations of engineering and R&D laboratories, ensuring laboratories are organized, fully functional, and operating efficiently.
• Develop, implement, and continuously improve laboratory processes, workflows, and standard operating procedures (SOPs).
• Coordinate laboratory scheduling, equipment availability, and resource utilization across multiple project teams.
• Maintain laboratory cleanliness, organization, and compliance with safety and quality standards.

Equipment & Asset Management

• Manage laboratory equipment lifecycle including procurement, installation, calibration, preventive maintenance, repairs, and retirement.
• Maintain equipment inventories and calibration records.
• Coordinate with vendors for equipment servicing and technical support.
• Evaluate and recommend new laboratory equipment and technologies to improve productivity.

Compliance & Quality

• Ensure laboratory operations comply with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, Good Documentation Practices (GDP), and applicable safety regulations.
• Support internal and external audits by maintaining laboratory documentation and records.
• Develop and maintain laboratory SOPs, work instructions, and operational documentation.
• Promote continuous improvement and operational excellence initiatives.

Safety & Facilities

• Serve as the laboratory safety lead by ensuring compliance with OSHA, chemical hygiene, biosafety, and environmental health and safety requirements.
• Coordinate hazardous waste disposal and chemical inventory management.
• Partner with Facilities and EHS to maintain laboratory infrastructure and resolve operational issues.
• Conduct routine laboratory safety inspections and corrective actions.

Inventory & Supply Chain

• Manage laboratory consumables, chemicals, reagents, and supplies to ensure uninterrupted operations.
• Establish inventory controls and reorder processes.
• Work with Purchasing and Supply Chain to source laboratory materials and negotiate with vendors.
• Monitor laboratory operating budgets and identify cost-saving opportunities.

Cross-Functional Collaboration

• Partner with R&D, Product Development, Manufacturing, Quality, and Regulatory teams to support product development activities.
• Coordinate laboratory support for verification, validation, and design testing.
• Support onboarding and training of laboratory personnel on equipment and laboratory procedures.
• Drive operational improvements that increase laboratory efficiency and scalability.

Leadership

• Mentor laboratory technicians and support staff.
• Prioritize laboratory activities to align with business objectives and project timelines.
• Foster a culture of safety, collaboration, accountability, and continuous improvement.

Qualifications

Required

• Bachelor's degree in Engineering, Biology, Chemistry, Biomedical Engineering, Life Sciences, or a related technical discipline.
• 5+ years of laboratory operations or laboratory management experience within a medical device, biotechnology, pharmaceutical, or regulated manufacturing environment.
• Experience supporting product development laboratories.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and laboratory safety standards.
• Experience managing laboratory equipment, calibration programs, and vendor relationships.
• Strong organizational, project management, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.

Preferred

• Experience in Class II or Class III medical device development.
• Experience implementing Lean, Six Sigma, or continuous improvement methodologies.
• Familiarity with electronic quality management systems (eQMS), laboratory information management systems (LIMS), or asset management software.
• CAPM, PMP, Lean Six Sigma Green Belt, or similar certification is a plus.

Key Competencies

• Operational Leadership
• Laboratory Management
• Regulatory Compliance
• Process Improvement
• Project Coordination
• Equipment Lifecycle Management
• Inventory & Supply Planning
• Risk Management
• Cross-Functional Collaboration
• Budget Management
• Vendor Management
• Continuous Improvement

Working Conditions

• Primarily onsite in a laboratory environment.
• Ability to lift up to 30 pounds and move laboratory equipment as needed.
• Occasional travel to vendor sites or company facilities may be required.

Success Measures

• High laboratory uptime and equipment availability.
• On-time support for engineering and product development activities.
• Successful completion of internal and external audits.
• Reduced laboratory downtime through preventive maintenance and operational improvements.
• Strong safety performance with minimal incidents.
• Efficient inventory management and cost control.
• High stakeholder satisfaction across Engineering, Quality, and R&D teams.