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Boston Scientific

Medical devices maker for interventional specialties

Senior Production Supervisor - Manufacturing

Manufacturing & Production OperationsConfirmed live in the last 24 hours
Full-timeCarlsbad, CA, USA

About the Job

Requirements

  • An associate or bachelor's degree in engineering, manufacturing or a related technical discipline, or equivalent experience.
  • At least 5 years of experience in a regulated manufacturing environment, preferably within the medical device industry.
  • At least 2 years of 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 Good Manufacturing Practice requirements.
  • Ability to work in a fast-paced manufacturing environment requiring 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 and laser safety equipment in accordance with established safety procedures.

Responsibilities

  • 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, including throughput, yield, efficiency and scrap, and implement continuous improvement initiatives to optimize manufacturing performance.
  • Ensure compliance with applicable Good Manufacturing Practices, 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 and batch records, in accordance with applicable regulatory requirements.
  • Lead root cause investigations, support corrective and preventive action 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, process validations including installation qualification, operational qualification and performance qualification, 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.
  • Foster a culture of accountability, teamwork, quality and continuous improvement while supporting employee engagement and development.

Desired Qualifications

  • Experience implementing laser safety protocols and working with Class 3B or Class 4 laser systems.
  • Experience supporting design transfer, new product introduction or manufacturing scale-up activities.
  • Experience using enterprise resource planning systems and digital work instructions.
  • Lean Six Sigma certification or training in continuous improvement methodologies.

About the Company

Boston Scientific

Medical devices maker for interventional specialties

Boston Scientific designs and makes medical devices used in procedures across cardiology, endoscopy, urology, and neuromodulation. Its products help doctors diagnose and treat conditions by guiding minimally invasive interventions and delivering therapies inside the body, with revenue from hospitals and clinics. The firm differentiates itself through a broad, global portfolio and heavy ongoing investment in research and development to expand capabilities and address complex health issues. Its goal is to improve patient care by providing reliable, effective medical devices and solutions that enable clinicians to perform safer, more effective procedures while growing its business.

Company size
10,001+
Company stage
IPO
Headquarters
Marlborough, MA
Founded
1979

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