Senior Manufacturing Operations Manager

2 weeks ago


Reston, Virginia, United States Bolt Medical Full time

Job Title: Senior Manufacturing Supervisor

Job Summary:

The Senior Manufacturing Supervisor will oversee Catheter Manufacturing Operations at Bolt Medical. This position is responsible for leading and coordinating production activities, ensuring compliance with quality standards, and driving continuous improvement initiatives to optimize efficiency and productivity.

Key Responsibilities:

  • Lead and supervise a team of Product Builders, ensuring adherence to standard operating procedures (SOPs), Manufacturing Process Instructions (MPIs), and safety protocols.
  • Provide guidance, training, and mentorship to production staff to enhance skills, knowledge, and performance.
  • Foster a positive and collaborative work environment that promotes teamwork, accountability, and continuous improvement.
  • Develop production schedules and allocate resources to meet production targets and customer demand.
  • Monitor production processes and workflow to identify bottlenecks, inefficiencies, and opportunities for improvement.
  • Implement strategies to optimize production output, minimize downtime, and reduce lead times.
  • Ensure compliance with regulatory requirements, including FDA QSR, ISO 13485, and MDR, as well as company quality standards and procedures.
  • Conduct regular inspections and audits of production areas to ensure adherence to quality standards and identify areas for improvement.
  • Investigate and resolve quality issues and non-conformances in collaboration with Quality and other departments.
  • Identify opportunities for process improvement and optimization to enhance efficiency, reduce waste, and improve product quality.
  • Implement lean manufacturing principles and continuous improvement methodologies to drive operational excellence.
  • Lead and participate in cross-functional teams to implement process improvements and address production-related challenges.
  • Maintain accurate production records, including production reports, inventory records, and quality documentation.
  • Prepare and present regular reports on production performance, including key performance indicators (KPIs), to management and stakeholders.
  • Document and communicate production issues, challenges, and solutions to relevant stakeholders in a timely manner.
  • In collaboration with department management and R&D, plans and executes the transfer of products from Research and Development into Manufacturing
  • Identifies training gaps and needs. Develops and delivers training to assemblers on the proper use of Manufacturing Instructions
  • Sets work schedules and develops training schedules for new employees and evaluates performance
  • Support Manufacturing and Quality Engineers in product investigations.
  • Support inventory counts by owning Work Order Open/Closing on ERP System

Requirements:

  • Bachelor's degree in Engineering, Operations Management, or related field; Master's degree preferred.

Preferred Qualifications:

  • 5+ years of supervising manufacturing production, operations experience in medical device, laboratory, diagnostics, or related industry experience.
  • Strong leadership and supervisory skills, with the ability to motivate and inspire a team to achieve goals and objectives.
  • A thorough understanding of Clean Room requirements
  • Ability to create and adhere to effective schedules.


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