StarsHR has the following long-term contract opportunity available with our client in Pittsburgh.

Biomedical Engineer

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):

Bachelor’s 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

W2 applicants only, please. Absolutely no third-party or agency submitted candidates will be considered. Sponsorship will be considered for well-qualified candidates.