Cleanroom Manager or Director

Job Summary:

Effectively manage ECA Medical’s Clean Room Operations to achieve quality, schedule, and performance goals. Oversees both cleanroom’s at Anchor A and Tourmaline.

Duties and Responsibilities:

· Manage component and assembly operations, materials, equipment, processes, and people to achieve production goals.

· Analyze and determine the organizational structure and manpower requirements that will most effectively meet the company’s manufacturing objectives.

· Contribute to the development of the company’s short-term growth and long-term strategic plans.

· Develop and regularly report performance metrics.

· Ensure proper work instructions, equipment, and tooling are created, maintained, and utilized to drive production.

· Provide direction and leadership to the Clean room and Manufacturing Engineering teams to achieve goals.

· Work with cross functional departments to implement safety, quality, customer services, and productivity improvements.

· Lead meetings to prioritize, plan and communicate production activities to achieve goals.

· Prioritizes production schedules, equipment efficiency and materials supply, to support the introduction of new products.

· Manage inventory of routine operating supplies for timely delivery.

· Support complaint investigations to ensure timely response and effective corrective actions.

· Maintain awareness and comply with the Quality Management System, ISO 13485, CFR for Medical Devices, and any applicable laws and regulations as they apply to the position.

· Complete any planned quality and compliance training within the required deadlines.

Qualifications:

· Bachelor’s degree in Engineering (or similar discipline) and/or equivalent experience

· Experience managing in a manufacturing environment; preferably with medical device, ISO 13485

· History of production leadership experience, performance metric management, and team development to achieve goals

· Prior experience with new product launches, inventory controls, GMP/GDP, and workforce planning

· Strong analytical, communication and leadership skills

· Proficient with Microsoft Office: Excel, Powerpoint, Word, Teams, Visio

· Ability to work well under pressure

Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.

Physical Requirements:

Sitting, standing, walking, bending, lifting up to 40lbs; pull/push up to 60 lbs, grasp small device/products and identify very small variations in the product. Sight is required for observing work and production. May spend several hours using a computer to create reports, analyze data and respond to inquiries and issues. May be exposed to active machinery and moving equipment, dust. Some time is spent traveling to other business locations; occasionally transporting product or materials.

Job Type: Full-time

Pay: $97,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• Cleanroom Management: 3 years (Required)
• Manufacturing: 3 years (Required)

Ability to Relocate:

• Newbury Park, CA 91320: Relocate before starting work (Required)

Work Location: In person