Technical Program Manager

Job DetailsJob LocationSolon, OHDescriptionJob Title: Technical Program ManagerDepartment: Program ManagementReport to: Director of Program ManagementFLSA Status: ExemptSummaryThe Technical Program Manager must be customer service oriented, have a strong technical background, business acumen, strong project management skills, strong knowledge of the medical device manufacturing process, and a desire to meet or exceed all customer expectations. They must work with customers and operations to successfully launch new products into production, understand the program needs and perceptions of the customer. They must anticipate and resolve technical, quality, and process issues. They must be able to lead, coordinate, and secure buy-in throughout the company to achieve customer expectations and attain our profitability goals.Essential FunctionsResponsible for the new product introduction (NPI) process and new order launch process.Provide technical support for our Sales and Program Management teams. Attend customer meetings, review customer technical data, articulate our technical strengths and capabilities, and win the customers confidence. Travel to customer meetings as required.Ensure new product launches comply with ISO-13485 and FDA 21CFR820 requirements.Primary point of contact for all technical communication between the customer and company associates.Interface with Operations, Quality, and Supply Chain departments regarding technical issues.Anticipate and resolve disruptive NPI issues prior to first production to ensure smooth product flow and on time delivery.Assist and support the development of the Device History Record (DHR), Production Failure Mode Effect Analysis (PFMEA), test records, validations, and customer required documentation.Responsible for the customer experience. An excellent listener and responsive communicatorWrite ECNs and Deviations to release documentation and ensure all revision changes are documented. Support all quotes with analysis of RFQ technical data, sub-assembly diagram, bom import, and labor estimates.Create and maintain schedules and track open issues.Work closely with interdisciplinary teams to successfully deliver new products on time and on budget including understanding scope, developing product launch plans, tracking progress to deliverables, and managing quoted cost to actual cost. Education And SkillsThe Technical Program Manager must have a Bachelor’s degree or equivalent. A minimum of one year of medical, aerospace, operations, and/or customer-facing experience. Additional skills below are preferred.A minimum of one (1) year new product launch or device manufacturing experience Proficient with CAD, SolidWorks, Altium, KiCAD, and the Microsoft Office suite Excellent listening, written, presentation, and verbal communication skills.Highly organized team leader successfully leading cross functional teams.Strong knowledge of ISO 13485 and FDA 21CFR820 requirements for medical device manufacturing. Ability to design and create solutions that meet the company and customer goals concurrently.QualificationsThe Technical Program Manager must have a Bachelor’s degree or equivalent. A minimum of one year of medical, aerospace, operations, and/or customer-facing experience. Additional skills below are preferred.A minimum of one (1) year new product launch or device manufacturing experience Proficient with CAD, SolidWorks, Altium, KiCAD, and the Microsoft Office suite Excellent listening, written, presentation, and verbal communication skills.Highly organized team leader successfully leading cross functional teams.Strong knowledge of ISO 13485 and FDA 21CFR820 requirements for medical device manufacturing. Ability to design and create solutions that meet the company and customer goals concurrently.