X-Ray Systems Sr R & D Engineer

X-Ray Systems Senior R & D Engineer - Liaison to Operations and Customer Support

Location: Garner, NC

This position is to be performed on-site. The option to work from home 1-2 days a week may be considered.

Position Overview:

This position is responsible for the research, design and development of our X-Ray equipment, while serving as liaison to Operations and Customer Support. This position is responsible for systems engineering and primarily for the design transfer to production, service, support and training, and also technical support to our customers, dealers, and field engineers.

• Ability to train other engineers.
• Carry out and lead technical investigations to ensure the highest level of customer satisfaction.
• Design transfer to production, service, support, training and supplier development and management.
• Systems engineering design, prototype development and testing based on requirements.
• Work closely with sales and customer service departments to ensure customer satisfaction.
• Work independently and also as part of the team.

Essential Functions & Responsibilities:

• Develop system and subsystem-level design specifications based on requirements
• Displays highly developed organizational skills.
• Serve as design transfer liaison to Manufacturing, Service, Support, and Training
• Serves as a Representative for KMHA conventions and shows
• Serve as technical support for key products to our customers, dealers and field engineers
• Complete and submit all required design control documentation on time and accurately
• Completes the Corrective Actions Policy as prescribed by KMHA
• Develop system and subsystem-level configurations
• Provide emergency on-call services as needed in partnership with Service and Support.
• Understands and Complies with all FSE Guidelines as applicable to the role.
• Completion of additional projects and assignments as given by management.
• Must comply with KMHA Radiation Safety Policy including the timely replacement of used badges
• Utilize exceptional interpersonal and communication skills for problem situations with customers and/or staff.
• Completes assigned training and development courses assigned by management team
• Prototype and test new circuit boards and improved revisions of existing circuit boards following medical devices design control methodology.
• Ability to prioritize, plan, and execute are key success factors in this position.
• Develop system and subsystem-level test methods and protocols

Education:

• Bachelor’s / Associates degree in Biomedical, electrical, mechanical engineering or computer science. Master’s degree preferred.

Education Plus:

• Certification in Laboratory Equipment (CLES)
• Certified Radiology Equipment Specialist (CRES) designation (www.aami.org)
• Certifications in Biomedical Equipment (CBET)

Experience:

• At least 8 years’ experience with medical devices systems and hardware design under design control, X-ray imaging technologies a big plus.
• X-ray physics and fundamental diagnostic X-ray imaging.
• Risk management (ISO 14971)
• Usability of medical devices as it relates to safety (IEC 62366)
• Proficiency with electrical engineering laboratory testing (oscilloscopes, function generators, spectrum and network analyzers etc).At least 3 years’ project management experience with medical devices design and commercialization under design control, X-ray technologies a big plus
• Design control (MDSAP and ISO 13485)
• Working knowledge of IEC 60601 standard required - ESD/EMI/EMC testing knowledge required

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Design - Demonstrates attention to detail.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget;.

Technical Skills - Assesses own / others - strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.

Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality and follows HIPPA guidelines; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Generally displays a positive attitude while working within the environment.

Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Leadership - Exhibits confidence in self and performance of their duties

Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.

Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Sets goals and objectives;

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Motivation -Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence (FSE Guidelines)

Quantity -Completes work in timely manner; Strives to increase productivity; Works quickly, smartly, and efficiently.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.

Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at appointments on time.