Senior Laser Medical Device Production Supervisor

Boston Scientific; Carlsbad (CA); Sur place; USD 89 000 - 170 000; Plein temps

Résumé du poste

Boston Scientific seeks a hands-on Senior Production Supervisor to lead daily operations for the assembly, testing and production of laser-based console systems. This on-site role in Carlsbad requires strong technical leadership, a focus on quality, safety and continuous improvement, and collaboration with cross-functional teams to ensure GMP and regulatory compliance.

You will mentor technicians, manage KPIs and drive Lean initiatives to sustain peak performance.

Qualifications

• Minimum 5 years in a regulated manufacturing environment (medical devices).
• Minimum 2 years in a direct supervisory or team leadership role.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with laser system assembly or optics handling.
• Strong problem-solving, communication and leadership skills.

Responsabilités

• Supervise daily manufacturing operations, including production scheduling, assembly, testing and packaging of laser-based medical console systems.
• Provide technical guidance, coaching and operational support to manufacturing technicians and assemblers to achieve production and quality objectives.
• Monitor KPIs, including throughput, yield, efficiency and scrap, and implement continuous improvement initiatives.
• Ensure compliance with GMP, ISO 13485, FDA 21 CFR Part 820 and quality management system requirements.
• Collaborate with Quality, Engineering and Supply Chain to resolve nonconformances and support design transfers and validations.
• Maintain accurate manufacturing documentation (WOs, DHRs, batch records) per regulatory requirements.
• Lead root cause investigations and CAPA activities; document deviations.
• Train and develop manufacturing team on SOPs, safety, and processes.
• Support ECOs, IQ/OQ/PQ, and equipment qualification activities.
• Ensure calibration, preventive maintenance and safe operation of laser systems and tools.
• Promote 5S and lean manufacturing to maintain an organized production environment.
• Foster accountability, teamwork and continuous improvement while engaging employees.

Connaissances

leadership

manufacturing supervision

problem-solving

communication

team leadership

Formation

Associate or Bachelor's degree in engineering/manufacturing or related technical discipline

Outils

ERP systems

Description du poste

Boston Scientific seeks a hands-on Senior Production Supervisor to lead daily operations for the assembly, testing and production of laser-based console systems. This on-site role in Carlsbad requires strong technical leadership, a focus on quality, safety and continuous improvement, and collaboration with cross-functional teams to ensure GMP and regulatory compliance.

You will mentor technicians, manage KPIs and drive Lean initiatives to sustain peak performance.