Project Manager

Summary:

Under the general direction of the President & CEO, the Project Manager will serve as a customer-facing representative and coordinate projects between KX Medical customers, vendors, suppliers, and internal team members. The Project Manager is responsible for organizing and driving customer projects from initial inquiry and development through qualification, production launch, and ongoing manufacturing support. This position will ensure project requirements, responsibilities, timelines, customer expectations, pricing considerations, and internal commitments are clearly communicated, documented, and completed.

Major Responsibilities:

Project Management

• Serve as a point of coordination for assigned customer projects.

• Manage projects from initial customer request through development, qualification, production launch, and ongoing manufacturing support.

• Develop and maintain project schedules, milestones, responsibilities, action items, and required completion dates.

• Coordinate activities between customers and KX Medical departments including Operations, Engineering, Quality, Regulatory, Purchasing, Production, and Management.

• Identify project risks, resource constraints, supply issues, quality concerns, and schedule conflicts and escalate issues as appropriate.

• Coordinate prototypes, samples, engineering builds, qualification activities, validation activities, first articles, and production launches as required.

• Assist with the transition of new projects from development into routine production.

• Maintain organized project records, customer correspondence, meeting notes, specifications, schedules, approvals, and other applicable documentation.

• Manage multiple projects and priorities simultaneously while maintaining appropriate follow-up and attention to detail.

Pricing and Cost Modeling

• Coordinate the development of pricing and cost models for new and existing customer projects.

• Gather and organize cost inputs including raw materials, purchased components, labor, machine time, tooling, outside processing, packaging, testing, scrap assumptions, overhead, freight, and other applicable project costs.

• Work with Purchasing, Operations, Engineering, Production, Quality, and Management to validate assumptions used in cost models.

• Develop and maintain accurate project costing worksheets and supporting documentation.

• Evaluate the financial impact of changes in materials, processes, volumes, labor requirements, supplier pricing, and other project variables.

• Assist Management in preparing customer quotations and pricing proposals.

• Maintain confidentiality of KX Medical costing, margin, pricing, supplier pricing, and other proprietary commercial information.

Customer Relations

• Serve as a communication link between the customer and KX Medical.

• Obtain and communicate customer requirements, specifications, forecasts, schedules, priorities, and changes to the appropriate KX personnel.

• Coordinate customer visits, project reviews, technical meetings, audits, and other customer activities as required.

• Work with internal KX personnel to respond to customer questions and resolve technical, quality, production, delivery, pricing, or documentation issues.

• Support investigation and resolution of customer complaints and corrective actions as required.

• Identify potential additional opportunities with existing customers and communicate those opportunities to Management.

• Maintain confidentiality of customer drawings, specifications, pricing, intellectual property, and proprietary information.

Administration

• Maintain current project schedules, action-item lists, project documentation, costing information, and customer correspondence.

• Communicate significant customer, supplier, schedule, quality, technical, cost, or commercial issues to Management promptly.

• Develop an overall understanding of KX Medical manufacturing capabilities, converting processes, materials, adhesives, products, customers, and markets.

• Develop a working understanding of applicable KX Medical Quality Management System requirements.

• Follow all applicable KX Medical policies and procedures.

• Perform other duties and responsibilities as assigned by Management.

Authority:

• Can schedule and conduct customer, supplier, and internal project meetings.

• Can communicate approved project information, schedules, requirements, and status to customers and suppliers.

• Can develop pricing and cost models for Management review.

• Can request internal and supplier cost information necessary to develop project cost models.

• Can escalate customer, supplier, quality, cost, schedule, or project concerns to Management.

• Has the authority and independence to perform tasks in accordance with this job description.

• Does not have independent authority to approve product pricing, customer quotations, changes to product specifications, manufacturing processes, quality requirements, regulatory requirements, customer contracts, or other controlled requirements without appropriate authorization.

Education / Experience:

• Bachelor's Degree preferred in Business, Engineering, Operations, Project Management, Manufacturing, Finance, or a related discipline. Equivalent relevant experience may be considered.

• Minimum of 3-5 years of project management, customer account management, manufacturing, engineering, operations, costing, or related professional experience preferred.

• Experience in medical device manufacturing, contract manufacturing, converting, or another regulated manufacturing environment preferred.

• Experience developing product costing, quotations, pricing models, or manufacturing cost estimates preferred.

• Strong project-management and organizational skills.

• Strong numerical and analytical skills with the ability to understand manufacturing costs and pricing inputs.

• Ability to manage multiple projects, priorities, deadlines, and responsibilities simultaneously.

• Strong customer-service orientation and professional communication skills.

• Effective presentation, oral, and written communication skills.

• Excellent analytical and problem-solving skills.

• Excellent judgment and decision-making abilities.

• Strong attention to detail and follow-through.

• Ability to take initiative and work independently in the absence of day-to-day supervision.

• Ability to work effectively with employees at all levels of the organization.

• Ability to lead and coordinate cross-functional activities when project participants do not directly report to the Project Manager.

• Ability to read and understand customer specifications, drawings, project requirements, and manufacturing documentation.

• Strong Microsoft Excel skills, including the ability to develop and maintain costing and pricing models.

• Proficient computer skills including Microsoft Excel, Outlook, Word, PowerPoint, and Teams.

• Familiarity with ISO 13485, FDA Quality System requirements, document control, change control, CAPA, validation, and supplier-quality concepts preferred.

• Excellent auditory and visual perception required.

• Must possess a valid Driver's License and a safe driving record.

• Travel to customers, suppliers, trade shows, and other business locations as required.