Production Operations Leader

2 weeks ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

POSITION OVERVIEW

The Production Operations Leader is accountable for managing all aspects of manufactured goods, value-added services, and the daily functions of the organization's production facilities. This role involves planning, coordinating, and directing the processes that yield finished products. Key responsibilities include overseeing manufacturing, scheduling work, managing production personnel, establishing work protocols, and ensuring quality standards are met. Additionally, this position encompasses capacity planning, ramp-up initiatives, budget compliance, goal setting, performance evaluations, and continuous improvement projects aimed at enhancing production metrics. The Production Operations Leader collaborates closely with Research & Development, Clinical teams, and Supply Chain to ensure adherence to build plans and inventory management.

KEY RESPONSIBILITIES

  • Oversee clean room assembly and testing operations while ensuring adherence to effective clean room practices.
  • Coordinate personnel, testing equipment, and instruments to meet production build plans, ensuring that schedules are upheld and product quality is maintained at the highest standards.
  • Strategically plan and optimize the utilization of manufacturing personnel and equipment to achieve production objectives.
  • Work collaboratively with the team to identify and implement opportunities for improvement within the manufacturing process.
  • Regularly assess operational efficiency and implement necessary adjustments to maximize workforce and operational productivity.
  • Plan, schedule, and manage one or more manufacturing production processes effectively.
  • Assist in the planning and direction of an efficient layout for equipment and material flow.
  • Ensure compliance with all safety regulations on the manufacturing floor.
  • Recruit, train, and maintain a staffing schedule for new team members.
  • Develop and cultivate a successful production operations team, ensuring the availability of necessary staff, skills, knowledge, and tools to meet production targets.
  • Maintain inventory oversight and communicate levels to management, procure inventory items, and liaise with suppliers.
  • Effectively communicate status updates, timelines, and critical issues to all organizational levels.
  • Develop standard operating procedures and assist in their implementation. Revise manufacturing documentation, processing documents, and SOPs as needed.
  • Collaborate with R&D and Quality teams regarding new product introductions.
  • Serve as a subject matter expert for manufacturing during various audits conducted by clients and regulatory agencies.
  • Advise leadership on factors that may impact product quality, initiate reports for deviations and non-conforming materials, and provide guidance for corrective and preventive actions (CAPA).
  • Manage capacity planning to ensure alignment with build plans.
  • Oversee the hiring and training strategy for production builders and support teams.
  • Create labor event charts to forecast improvements in labor standards.
  • Support and initiate productivity projects to enhance the financial performance of operations.
  • Own ramp-up and ramp-down strategies to meet demand fluctuations.
  • Lead the Industrial Engineering and Training Department.

EDUCATION AND EXPERIENCE REQUIREMENTS:

  • Bachelor's degree in business, manufacturing, or engineering.
  • 5+ years of experience in production management within a medical device manufacturing environment, preferably in a cleanroom setting.
  • Experience in the manufacturing of catheter products is advantageous.
  • Strong understanding of current Good Manufacturing Practices (GMP) and ISO 13485 standards.

SKILLS AND COMPETENCIES:

  • Experience with continuous improvement processes.
  • Excellent communication and organizational abilities.
  • Ability to collaborate effectively with individuals at all organizational levels.
  • Comprehensive understanding of clean room requirements.
  • Proven ability to lead a diverse team of manufacturing personnel.

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