Manufacturing Manager

This position is responsible for the efficient and timely production of the company’s product in accordance with established procedures, quality standards, and customer specifications. Responsible for production personnel, production capacity and providing a positive atmosphere conducive to continuous improvement for quality and efficiency.  

  • Reports to: Chief Executive Officer
  • FLSA: Exempt
  • Last Updated: March 2022

Principal Roles and Responsibilities

Essential Functions of the Positions

  • Learn products and processes to appropriately support the customers and business.
  • Utilize IT tools for efficient execution of duties (IQMS).
  • Knowledge of Quality Management System (QMS).
  • Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
  • Understanding that device defects may occur from improper performance of specific job function.
  • Professional written and oral communications.
  • Ethics aligned with the company’s mission.
  • Set goals for team or personnel reporting as per the organizational structure.
  • Utilization of IT tools provided to ensure work is organized to prevent errors and omissions.
  • Work product for clients is organized, reviewed and complete.
  • Adherence to the company policies and employee handbook.
  • Assess sales history and projections to set “min/max”.
  • Continues workload evaluation to ensure proper workload.
  • Assigns employees with the appropriate skills to respective production tasks.
  • Ensures efficient collaboration and coordination between and within the departments.
  • Responsible for Corrective Action Preventative Action (CAPA) with the Quality Manager.
  • Responsible for producing quality parts.
    • Checks all machines periodically to ensure that they are performing according to company standards.
    • Coordinate with Quality Control on product issues.
    • Responsible for ensuring that all machines are adequately maintained.
    • Ensure that all products adhere to FDA and ISO regulations.
    • Continuously look for improvements to the lean and 5s systems.
  • Coordinate with Research and Development (R&D) on upcoming projects and R&D runs for prototype.
  • Estimate production costs and accordingly set production budgets and then manage production budgets by implementing cost control programs.
  • Track scrap and down time for machines.
  • Ensures company policies and procedures are followed to ensure conformance and consistency of products.  Remains current on all company policies and procedures.
  • Sets achievable and realistic production goals for employees based on demand, history, timing experience and company needs. 
  • Provides employees with the necessary tools to be successful in their jobs.
  • Regular attendance
  • Abides by all safety and security rules set forth by the company and regulatory agencies.
  • Performs all other duties and responsibilities assigned by the Chief Executive Officer or its designated representative.

Supervisory Responsibilities

  • Responsible for staffing, supervising and performance management of department employees to include disciplinary action. Disciplinary action to be reviewed by Human Resources.
  • Participate in staff management training and effectively manage employees in compliance with federal and state employment laws and regulations.
  • Interview, hire, and train new department employees.
  • Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth. Performance reviews to be reviewed by Human Resources.
  • Conduct regular staff meetings.

Minimum Qualifications

Qualifications & Experience

  • 10 (ten) years manufacturing experience required.
  • Experience working in the medical device manufacturing industry preferred.
  • Background in mechanical or industrial engineering preferred.
  • Mechanical ability.
  • Excellent communication and interpersonal skills.
  • 5 (five) years’ supervisory experience, required
  • Proficient with Microsoft Office.

Education

  • Bachelor’s Degree in engineering or Business, preferred.  Equivalent work life experience desired.

Competencies

  • Flexible in responding to procedural changes and department/ employee needs and issues.
  • Strong analytical skills with the ability to resolve problems by gathering necessary information to make an effective resolution.
  • Ability to remain calm under pressure.
  • Strong interpersonal skills in working with employees and other departments.
  • Strong communication skills.
  • Personal accountability.
  • Detail oriented with attention to accuracy.
  • Deadline oriented.
  • Patience in dealing with employee and interdepartmental issues.
  • Good judgment with the ability to make sound decisions.
  • Leadership skills with the ability to coach, motivate, and guide employees.

Special Work Conditions

This position requires 2-5 hours per day standing, sitting, walking, climbing stairs, talking, and listening.  Lifting to 50 lbs 0-2 hours per day.  Exposure to moving mechanical parts and risk of electrical shock 0-2 hours per day.  Moderate to loud noise level. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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