Director, Quality

Job Title Medical Device Service Engineer Requisition JR000015824 Medical Device Service Engineer (Open) Location Madison, WI Additional Locations Job Description Summary The Medical Device Service Engineer role blends hands-on technical work with clear, accurate documentation, technical writing and requires strong communication skills to support customers, internal teams, and regulatory needs. The ideal candidate is detail oriented, comfortable working in clinical or laboratory environments, and experienced with GxP aligned processes. This role provides guidance and support of service methods/processes, tooling, equipment, test systems, troubleshooting and repairing medical devices in compliance with regulatory, quality and good documentation standards to ensure effective and timely medical device servicing activities. Ensures compliance with the company quality system, in accordance with the applicable Code of Federal Regulations, ISO 13485, customer and company requirements. Completes all assigned project work in a timely manner balancing customer and business requirements with technical and operational capabilities. Responsible for training and support of other Service personnel that perform scheduled maintenance and repair activities on INOmax devices. Provides Subject Matter Expert (SME) level technical expertise and support to ensure service procedures and manuals are current and compliant. This position will also play an important role in promoting teamwork between Regional Service Centers (RSC) service activities and manufacturing, to foresee problems with product assembly or service practices. Job Description Key Responsibilities : Mastery of all Service Technician requirements including Evolve Service Log analysis Develop in the role to train new Service Technicians – all levels Ability to create or update service procedures and service manuals as part of the change control process Supports the requirements of medical device design controls process from a Service aspect Supports new device launches regarding Service requirements Defines and updates as required the ERP process for recording Service documentation Utilize existing utility, workflow and business demand metric reports to manage the service workflow Trained as a technical expert on the existing service process and requirements Manage and/or participate in related project work as assigned Ensure compliance with Quality, Safety and Regulatory initiatives. Perform installation, calibration, preventive maintenance, and repair of medical devices and related systems. Diagnose technical issues using electronic, mechanical, and software‑based troubleshooting methods. Document service activities with clear, concise, and compliant manner. Ensure all work adheres to GxP, ISO, and company quality system requirements. Collaborate with engineering, quality, and product teams to escalate issues and support continuous improvement. Follow all safety protocols and maintain a professional presence in clinical and laboratory settings. Develop and revise service documentation (Standard Operating Procedures (SOP), Work Instructions (WI), Service Bulletins (SB), Process Flow Diagrams or other quality documentation, as necessary, to support service processes. Support all service methods, tooling, preventive maintenance, equipment calibration, test systems, and documentation ensuring compliance with company quality system and regulatory requirements. Work closely with Manufacturing Engineering, Sustaining Engineering, and GDE to improve service processes and design for service ability in a timely manner. Train Service Associates on new and/or revised service processes, equipment, and documentation. Proficient in standard office software (ie MS Word, Excel, etc.). Ability to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary. May perform other duties as required to meet business needs. Qualifications: Education / Experience: Bachelor of Science in Engineering (BSE) preferred; minimum of a two‑year technical degree in electronics, biomedical engineering, mechanical engineering, or related discipline is required or military equivalent training with 5+ years electromechanical maintenance experience required. Minimum of 1–3 years of related experience servicing medical devices, laboratory instrumentation, or comparable electromechanical systems. Demonstrated experience in technical writing, including preparation of service documentation, SOPs, or technical reports. Familiarity with GxP processes (GMP, GLP, GCP) and experience working in regulated environments (preferred). Strong analytical, diagnostic, and problem‑solving skills. Proficiency in reading schematics, using diagnostic tools, and working with software‑driven devices. Effective written and verbal communication skills with the ability to interact professionally with customers and internal teams. Ability to travel as required to support service operations Preferred Skills: Experience with FDA‑regulated medical devices or ISO 13485 environments. Knowledge of networking, device connectivity, or software‑driven instrumentation. Certification in biomedical equipment technology (CBET) or similar credentials Microsoft Office SAP Service module (SM) preferred Proficient in the existing Keenova service model for the INOmax platform Conducting training classes Detail oriented Excellent written and oral communication skills Able to analyze, prioritize and manage multiple tasks Technical analysis and evaluation Ability to perform root cause analysis and drives problems to resolution Organizational Relationship/Scope: Reporting to the Senior Manager, Technical Service, this position interfaces with other business units such as Global RSCs, Sustaining Engineering, Global Device Engineering, EHS, IT, Product Support and Quality. Working Conditions: Office environment, manufacturing/ servicing floor and Regional Service Centers service areas. Approximately 20% travel may be required Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. #LI-GN1 At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at .