Production Supervisor - 3rd Shift
Intracept by Boston Scientific
Manufacturing Supervisor
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
At Boston Scientific, we are seeking a hands-on Manufacturing Supervisor to lead daily operations for the assembly, testing and production of laser-based console systems classified as Class II medical devices.
In this role, you will provide technical leadership, oversee manufacturing performance and foster a culture of quality, safety and continuous improvement. You will work closely with cross-functional teams to ensure manufacturing processes comply with applicable regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820, while delivering high-quality products that meet customer and regulatory standards.
This is an opportunity to lead a dedicated manufacturing team, drive operational excellence and contribute to innovative medical technologies that improve patients' lives.
This role follows an on-site work model, requiring employees to work at our Carlsbad, California, facility four to five days per week.
Your responsibilities will include:
- 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 key performance indicators (KPIs), including throughput, yield, efficiency and scrap, and implement continuous improvement initiatives to optimize manufacturing performance.
- Ensure compliance with applicable Good Manufacturing Practices (GMP), ISO 13485, FDA 21 CFR Part 820 and established quality management system requirements.
- Collaborate with Quality, Engineering and Supply Chain teams to resolve nonconformances, implement process improvements and support design transfers and manufacturing validations.
- Maintain accurate and complete manufacturing documentation, including work orders, device history records (DHRs) and batch records, in accordance with applicable regulatory requirements.
- Lead root cause investigations, support corrective and preventive action (CAPA) activities, and document deviations to ensure timely and effective resolution.
- Train, mentor and develop manufacturing team members on standard operating procedures, safety protocols, technical processes and product knowledge.
- Support the implementation of engineering change orders (ECOs), process validations, including installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and equipment qualification activities.
- Ensure proper calibration, preventive maintenance and safe operation of laser systems, manufacturing equipment and production tools.
- Promote and enforce workplace safety, 5S methodology and lean manufacturing principles to maintain an organized, efficient and compliant production environment.
Qualifications:
Required qualifications:
- Associate or bachelor's degree in engineering, manufacturing or a related technical discipline, or equivalent experience.
- Minimum of 4 years' experience in a regulated manufacturing environment, preferably within the medical device industry.
- Experience in a direct supervisory or team leadership role.
- Working knowledge of laser system assembly, optics handling or electromechanical integration.
- Knowledge of ISO 13485, FDA 21 CFR Part 820 and applicable GMP requirements.
- Strong problem-solving, communication and leadership skills, with the ability to guide teams and resolve manufacturing challenges.
Preferred qualifications:
- Experience implementing laser safety protocols and working with Class 3B or Class 4 laser systems.
- Experience supporting design transfer, new product introduction (NPI) or manufacturing scale-up activities.
- Experience using enterprise resource planning (ERP) systems and digital work instructions.
- Lean Six Sigma certification or training in continuous improvement methodologies.
- Ability to work in a fast-paced manufacturing environment that requires prolonged standing, walking and occasional lifting of up to 50 pounds.
- Ability to follow cleanroom or controlled-environment protocols, as applicable.
- Ability to use required personal protective equipment (PPE) and laser safety equipment in accordance with established safety procedures.
$89.2k
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