Director, Manufacturing

The Director, Manufacturing, will have responsibility for manufacturing operations ensuring a formalized lean manufacturing structure. Key aspects include safety, timelines, critical milestones, and tracking of product and scrap to drive business impact and to maximize the workforce with targeted delivery balancing engineering problems and cost reductions while producing a consistently safe, quality product.

This role includes responsibility for manufacturing, manufacturing engineering, formulation laboratory, quality control, and warehouse functions.

• Directly oversees all consumables manufacturing operations for LightDeck and fulfillment operations for consumables and durables.
• Facility and production responsibility for Longmont site; pilot line responsibility for Boulder site
• Transfer, scale up, line balancing, and cost reduction activities.
• Writes and implements changes to controlled documents. Lead audits and work with outside regulatory agencies for manufacturing area.
• Prioritizes and resources benchmarking activities and participates in best practice sharing to drive competitive advantage.
• Works and acts as a strategic partner with business leaders in the development of the manufacturing business to effectively link inter-departmental objectives and to identify customer requirements and forecasted production.
• Manages production operations to achieve attainment of the production plan by developing and executing the short-term fixed schedules based on the master production forecast requirements.
• Ensure the supervision and training the production work force in methods and procedures that maximize the efficient operation and application of the means of production.
• Maintains capital equipment and operational budgets.
• Ensures all products, procedures, equipment, and policies are in compliance with relevant ISO, USDA, FDA and cGMP regulations.
• Maintains a safe, clean work area and implements environmental programs as appropriate.
• Manages supporting warehouse activities including inventory management, cycle counts, shipping, and receiving.
• Oversight of equipment maintenance.
• Manages personnel, organizes, and prioritizes group tasks, trains and assists operations supervisors in writing performance reviews.

Requirements

Education and Experience:

• Minimum of seven (7) years’ experience in manufacturing, engineering or quality related to manufacturing and scale up operations. Experience in lean manufacturing processes or related industry field and experience preferred.
• Minimum five (5) years in leadership position.
• Bachelor’s degree in Engineering, Bioengineering, Manufacturing, Business, Technical, Science or other related field.
• Able to work well in a team environment with various internal departments, customers, and outside exposure to contract manufacturers, vendors, business partners, FDA, ISO and other regulatory bodies and policies.
• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.
• Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP are a plus.
• Knowledge of current best practice manufacturing policies, procurement policies, practices and procedures, procurement systems, and supply chain management processes are a plus.

• Experience working with medical device industry required. In vitro diagnostics experience, preferred.
• Strong written and oral communication skills; must be able to deliver complex technical reports and communicate effectively with management, partners and technical audiences.
• Deep understanding of how to manage and document sensitive and confidential situations and materials and Intellectual Property.
• Deep understanding of documentation, safety, and other manufacturing and laboratory operations issues.

Benefits

Medical, Dental, Vision, matching 401k and generous PTO!

Working Conditions:

Work will normally be performed in a manufacturing/assembly environment which requires the donning of hair coverings, lab coats, PPE (protective eye wear). Work will be performed using mechanical and automated process equipment and will require standing, sitting, bending, twisting, lifting/carrying up to 25 pounds and monitoring outputs via visual inspection. Usage of phone, tablet and computer.

Starting Salary: $123,000 - $160,000 DOQ

LightDeck Diagnostics is an Equal Opportunity Employer committed to a culturally diverse workforce and is an Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbi