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.