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Biomedical Engineer
Indianola, PA
6-12 Months

POSITION SUMMARY This position will be responsible to perform
requirements management, verification and validation of medical devices
to deliver a high-quality product that meets or exceeds customer
expectations and meets FDA design controls.
POSITION DUTIES & RESPONSIBILITIES
  Activities Develop software verification protocols (manual and
automated) for the design and development of the system/subsystem,
review requirements, develop test scenarios, review and approve
protocols, perform the execution of the protocols, analyzes results, and
write reports Automating verification protocols for the design and
development of the system/subsystem, manages or performs the execution
of the protocols, analyzes results, and writes reports. Responsible for
verification around the various aspects of the software platform of the
medical device to account for user interactions, performance, safety and
functionality. Fulfilling activities to comply with the project
deliverables outlined in the Design and Development Plans and Design
Control Procedures, as applicable. Tracking and document discrepancies,
as applicable, during verification.

REQUIREMENTS/PREFERENCES Education Requirement(s):
Bachelors degree in Biomedical Engineering or a similar discipline.
Skill & Competency Requirements: Minimum of 1 year or more of full-time
relevant work experience or equivalent. Minimum of 1 year or more of
full-time relevant work experience developing and documenting
requirements for regulated medical systems.
Preferences: Experience designing and developing complex systems in a
regulated environment while adhering to FDA Design controls and software
processes guidelines for medical devices including ISO 13485, ISO 14971,
and IEC 62304 Experience with software utilizing medical image and
radiology standards and technologies including DICOM and HL7.
Exposure to programming in any of the following languages C#, Python or
C++ Experience working onsite in Hospital/Clinic to work directly with
physicians and technologists in order to elicit requirements and
feedback and develop new features within software per customer
specifications. Working knowledge of tools such as Rational Quality
Manager, Jenkins, TOSCA, JIRA, Git and DOORS Next Gen Ability to
troubleshoot and make quick knowledge and experience-guided decisions
Very good written and oral communication as well as strong presentation
skills Excellent people skills, ability to partner well, good team
camaraderie Proficient with Microsoft Office tools especially MS Word,
MS Excel, MS PowerPoint, MS Project, and other management tools.