Description

Our mission is to help clinicians manage their most complex patients.

Kreg’s Beds provide an innovative modality to get complex patients out of bed, mobilized and stabilized so they can progress to PT, LTACH, and ultimately home. Because not all the patients are the same, not all the beds should be the same. Kreg’s offers a unique portfolio of specialty beds and 24/7 rental services to allow clinicians to mobilize those complex patients safely and efficiently. We are a small company, on a mission to stand out from the crowd and make Kreg Beds the #1 hospital partner to deliver better outcomes for complex patients. 

The Production Manager will report directly to the Director of Production and Manufacturing. The Production Manager will manage their direct report team with responsibility for delivering service quality. 

As the Production Manager overseeing assembly operations, your pivotal role extends beyond supervision, encompassing leadership in implementing lean production principles. Adhering to FDA regulations, your directives must not only ensure compliance but also enhance overall production efficiency. Scalability is a primary consideration, and your strategic planning involves optimizing layouts and equipment flow to accommodate growth without compromising efficiency. You are the architect of the production landscape, directing the team, planning for future demands, and fine-tuning layouts. Your hands-on approach ensures seamless integration of lean principles, fostering a cost-effective and compliant production process. In summary, your responsibility spans leadership in lean practices, adherence to FDA guidelines, and strategic planning for scalable assembly operations. 

Responsibilities

The Production Manager - Assembly is responsible for leading all activities of the assembly including Safety, Quality, Delivery, Productivity, and Material Management.

• Ensure a safe work environment for all employees; establish, manage, and monitor standards, processes, communications, training, and systems as they relate to Environmental and Safety.
• Recruit, develop, support, and evaluate staff to manage roles and responsibilities for the achievement of results.
• Plan and assign production resources and workers to maintain desired output levels.
• Make adjustments to teams and resources to maintain the required production rate
• Provide vision, direction, and leadership for the formulation and implementation of Customer Quality and Assembly process improvements, employing Lean and Six Sigma tools.
• Delivery and Capacity Planning/On Time to Promise and Customer Request.
• Ensure proper utilization and uptime for assembly tooling, fixtures, and equipment.
• Develop plans to maximize the utilization of assembly assets and ensure the availability of resources per the changing business.
• Demonstrated ability to lead cultural change and establish operational metrics/key indicators for process control, communication, and performance improvement.
• Tasks will include the development, implementation, and maintenance of production-assembly documents, processes, and activities.
• You will be expected to work cross-functionally with Supply Chain, R&D, Quality, Regulatory Affairs, vendors, and contract manufacturers.
• As the Production manager is your responsibility to integrate lean production principles into the production process.
• Identifying and eliminating waste, optimizing workflow, and continuously improving processes to enhance efficiency and reduce costs.
• Prioritize scalability, ensuring that the assembly operations can adapt to changes in demand or production volume. This involves strategic planning, layout optimization, and the implementation of flexible processes and technologies to accommodate growth without compromising efficiency. 
• Upholding compliance with regulatory standards, particularly those set by the FDA is a critical principle. The Production Manager will lead efforts to ensure that all processes and products meet or exceed industry regulations. This includes implementing quality assurance measures, conducting regular audits, and fostering a culture of compliance within the production team. 
• Ensure processes, documents, materials, and equipment comply with applicable regulatory requirements including ISO13485, ISO 14971, cGMP, and FDA Production and Process Controls as per FDA 21CFR. 
• Generate batch records. - Generate Production order records. 
• Participates in investigations related to Nonconformance and/or Corrective and Preventive Actions related to manufacturing.

A successful manager and leader at Kreg Therapeutics must consistently demonstrate the following core management competencies: 

• Excellent problem solving and decision-making skills. 
• Ability to lead or work independently.
• Ability to manage scenarios with ambiguity. 
• A strong sense of urgency 
• An action equals results approach to all duties 
• Excellent collaboration, communication, and teamwork with all business partners 
• Lead organizational change through innovation 
• Honesty/Integrity 
• Motivating others while promoting growth opportunities within direct report team.
• Financial responsibility to the Organization and leading Operational Excellence initiatives 

Why work for Kreg Therapeutics? 

• Our products will allow you to make a significant impact in patient care as we serve your community to provide the highest standards of care.
• You’ll get closer to the mission. There’s less corporate jargon and bureaucracy getting in the way of what you can do and accomplish as a professional.
• You can wear many hats. Instead of delegating tasks, you’ll figure out how to get them done—and learn a lot in the process 
• You’ll work more closely with senior leaders. Instead of seeing the CEO once a year, you’ll work right next to him 
• You’ll experience a lot of camaraderie. Teamwork is a big part of our small family-like culture.
• You can move quickly on your ideas. If you have a proposal, you can try it out quickly without a lot of red tape.
• You can experiment. You’ll have plenty of chances to test new ideas—and you’ll be encouraged to do so.? We hate “boxes”, “lanes” and “silos”
• You’ll feel a sense of ownership.

Benefits include:

• Comprehensive Benefit package (Medical, Dental, Vision, 401K & Life Insurance)? 
• Paid travel expenses
• Kreg phone & laptop
• Vacation, Personal & Sick time

Requirements

• Bachelor's degree in engineering preferred
• Lean Six Sigma Certified
• Business Acumen, coupled with familiarity with ERP and MRP systems
• Demonstrated high quality of decision making
• Operating and Organizational Skills
• Has demonstrated the ability to successfully hire and recruit the best talent
• Action-oriented with the ability to stand alone and yet operate successfully
• Demonstrated success at utilizing Lean tools to drive productivity and efficiency
• High approachability factor, strong builder of effective teams, and a strong motivator of others
• A strong believer in personal learning and self-development
• Demonstrated ability to manage multiple, complex projects and changing priorities, make sound decisions, and work effectively in a technical environment
• Responsible for ensuring that employees are properly trained and audited for quality of work completed 
• Write and execute protocols leading to quality and productivity improvements in a proactive manner
• Coordinate/plan and execute the activities with Production/ Quality and Maintenance relevant to Conversion Cost Reductions, Scrap Reduction, and Material Cost Savings.
• Partners with Quality to ensure that products are produced in conformance with product specifications.
• Responsible for assigning production orders and scheduling processes from assembly to finished goods.
• Takes ownership and accountability for building the highest quality product (zero defects) efficiently Develop and implement programs to improve defects and enhance overall operation.
• Complete performance reviews for all individuals and identification and grooming of high-potential individuals to assume leadership roles.
• Responsible for the production of all company products according to cGMP, 21CFR Part 820. Oversees all QC release testing of company products.