Verification Engineer (2)
Our client is a mid-sized medical device firm seeking 2 Verification Engineers to join their Systems Engineering R&D team. This role is located in Northeast Atlanta. The firm is expanding their team and ideally seeking to bring aboard two individuals with corporate R&D experience, one with 2+ years of experience, the other with 5-10 years of background. Candidates should be familiar with system-based medical devices utilizing automated firmware. Writing protocols for execution and verification background are key elements of the role. The firm has a separate 'testing' department, but this individual will work with the testing team closely. Local candidates are preferred, but candidates from other locales will be considered. The firm will not pay for a full relo, but assistance may be provided depending on the candidate's background and credentials.
This role requires previous background in medical device development and system verification. The individual will be developing and implementing strategies for the creation of specific verification tests in the field of Software, Assay and Instrumentation for the firm's R&D department.
The candidate will:
- Assist with the creation and review of Assay, Software and System Requirements
- Develop Verification and Study Protocols to assure Requirements and Specifications are fulfilled
- Review results of executed Protocols and writing summary reports and providing conclusions
- Work with company's contractors and internal personnel to ensure effective communications, interpretation and implementation of our procedures
- Assist in Project and Product Risk Assessments
- Perform traceability analysis of test protocols to Requirements
- Interact cooperatively with co-workers, supervisors and managers of other departments and taking direction well from superiors
- Provide project management input regarding verification activities on projects
The candidate should have a background in medical device development and system verification, and will need excellent oral and written communications; ability to multi-task in a fast paced results oriented environment; and strong organizational skills and attention to details are required. Background in traceability and trace risk is a plus, as is risk management experience. Usability proofs, technical writing and design input background are pluses.
Additional requirements include:
- Bachelor's degree in Engineering, Biology, Medical Technology or related field
- MT (ASCP) certification designation is preferred but not required
- 2-10 years of verification experience in the medical device space, specifically with laboratory instrumentation and automations
- Ability to develop and test software and system requirements; track bugs, defects or abnormalities
- Strong understanding of document management principles and best practices
- Ability to learn new skills and adapt to changing environment