Software Program Manager Position Available In Wake, North Carolina

This position is responsible for the software program and agile project management for the research, design and development of our X-Ray equipment. The position also provides support of installation and servicing of our equipment and training and technical support to our customers, dealers, and field engineers. Software Program Management that aligns with market opportunities and company’s product roadmap. Agile Project Management for software development effectively driving cross-functional planning and execution of software releases for new product development and sustaining activities. Develop system and subsystem-level software test methods and protocols. Carry out and lead technical investigations to ensure the highest level of customer satisfaction.

ESSENTIAL FUNCTIONS/RESPONSIBILITIES

Develop and oversee software programs and projects designed to meet the organization’s goals, including developing charters and software roadmaps to include scope, resources, and timeline estimates. Prioritize software projects in agreement with the business cross-functional team (marketing, sales, production, R D, quality, regulatory). Apply Agile Project Management for software development. Ensure stakeholders buy-in and escalate issues. Level software projects’ resources based on business priority setting and resources availability. Facilitate conflict resolution for scope, time, and resources when needed. Ensure assigned resources to projects adequately perform projects tasks. Track projects execution against agreed scope and project metrics. Contribute to the organizations Program Management standardized operating procedures and guidelines. Ensure projects’ documentation is conducted in accordance with the company policies and procedures, and quality and regulatory requirements. Develop system and subsystem-level software test methods and protocols. Carry out software verification and validation following the design control process. Complete and submit all required design control documentation on time and accurately. In partnership with Service and Support diagnose technical equipment conducting root cause analysis and propose improvement solutions. Mentor junior engineers and contribute to knowledge sharing withing the R D group. Maintain tools and test equipment properly and ensure timely calibration. Completes assigned training and development courses assigned by management team. Provide emergency on-call services as needed in partnership with Service and Support. Serves as a Representative for KMHA conventions and shows. Understands and Complies with all FSE Guidelines as applicable to the role. Must comply with KMHA Radiation Safety Policy including the timely replacement of used badges. Completes the Corrective Actions Policy as prescribed by KMHA. Displays highly developed organizational skills. Ability to prioritize, plan, and execute are key success factors in this position. Utilize exceptional interpersonal and communication skills for problem situations with customers and/or staff. Completion of additional projects and assignments as given by management.

REQUIREMENTS & QUALIFICATIONS

Bachelor’s / Associates degree in Biomedical, electrical, mechanical engineering or computer science. Master’s degree preferred. PMP Certification. Agile Methodology Certification. Certified Radiology Equipment Specialist (CRES) designation (www.aami.org). Certifications in Biomedical Equipment (CBET). Certification in Laboratory Equipment (CLES). At least 5 years’ experience with medical devices design and commercialization under design control, X-ray technologies a big plus. At least 2 years experience leading software projects for development of X-Ray systems. Working knowledge of Project Management Book of Knowledge and Agile Methodology. Design control (MDSAP, IEC 62304 and

ISO 13485

). Risk management (ISO 14971). Usability of medical devices as it relates to safety (IEC 62366). Fundamental diagnostic X-ray imaging.