Senior Manufacturing Manager

Job Description:

POSITION SUMMARY

The Senior Manufacturing Manager for Perfusion Systems plays a pivotal role in ensuring the efficient production of high-quality Perfusion Systems. This position involves overseeing all aspects of the manufacturing process, managing production schedules, ensuring quality control and compliance to company procedures including FDA 21CFR820 and ISO 13485 standards. Responsibilities include managing and leading a team of manufacturing supervisors, coaching and mentoring the team to ensure performance objectives are met, fostering positive employee relations and building a strong culture of Safety, Quality and Continuous Improvement.

RESPONSIBILITIES:

Production Management:

• Establish manufacturing goals and drive operational execution to meet these targets.
• Monitor and manage key performance indicators (KPIs) such as Safety, Quality, Delivery, Inventory, Productivity, and Cost.
• Oversee daily production output, making real-time adjustments to ensure timely delivery of perfusion modules and accessories.
• Enhance production efficiency and minimize downtime and overtime through continuous process evaluation from initial assembly to final packaging.

Quality:

• Enforce quality standards to ensure produts meet or exceed usability and regulatory expectations.
• Collaborate with Quality, Supply Chain, and Manufacturing Engineering to resolve non conformances and streamline material flow to production.
• Leverage data to identify defect trends and collaborate on root cause analysis, corrective and preventive solutions.

Team Leadership:

• Recruit, train, and develop a high-performing production team.
• Mentor team members, providing support to achieve individual and team objectives, while promoting a culture of collaboration and continuous improvement.

Operational Efficiency:

• Identify and implement process improvements to boost efficiency and reduce costs.
• Champion lean manufacturing practices, 5S methodology, and standardized work processes across operations.
• Facilitate Tier meetings and follow up on action items to address operational gaps.
• Establish and track KPIs to monitor output, quality, and operational performance

Production Planning:

• Create and execute production plans aligned with customer demand and capacity.
• Develop accurate production schedules and forecasts to optimize resource utilization.

Health and Safety:

• Enforce safety standards and ensure a safe, compliant work environment.
• Promote adherence to health and safety protocols, including proper use of PPE such as bonnets, face masks, gloves, and gowns.

Cost Management:

• Prepare and manage the manufacturing budget, monitor expenditures, and identify cost-saving opportunities.

New Product Introduction:

• Collaborate with product development teams to facilitate the smooth transition of new products from design to full-scale production.
• Provide insights on manufacturability, scalability, and quality during product development phases.

Communication and Reporting:

• Maintain strong communication with cross-functional teams to align on production goals and priorities.
• Deliver weekly reports on production performance, issues, and continuous improvement initiatives.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• Two Supervisors – two 8 hour shifts
  • ~30 E/M Assemblers each shift

PHYSICAL ATTRIBUTES

• General Office Environment
• Clean Room environment
• May stand for long periods of time
• May lift up to 25 pounds                                                                                                    

MINIMUM Qualifications:

• Bachelor's degree in Industrial engineering, Business management, or a related field
• Minimum of 7 years of experience in Manufacturing roles, with at least 3 years in a leadership or managerial position within the medical device industry.

PREFERRED Qualifications:

• Masters Degree
• Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).
• Previous work experience with MES, eQMS, ERP systems preferred
• Demonstrated leadership and team management skills.
• Excellent problem-solving and decision-making abilities.
• Effective communication and collaboration skills.
• Familiarity with lean manufacturing principles and continuous i