Description

Position Summary:

Develop, support, and implement verification and validation activities through mentorship in the writing, execution, and summarization of verification and validation plans and protocols. The emphasis of this position is on engineering test and support for complex medical instruments in a manufacturing environment. Develop and execute design verification and equipment, process, and non-product software validation protocols.

Essential Job Duties and Responsibilities

• Lead verification and validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site and department initiatives.
• Work with multidisciplinary engineering team members to design, construct, author, and execute engineering, verification, and reliability tests and protocols.
• Write and execute protocols and test cases for verifications and validations.
• Assure validation documentation is generated, reviewed and approved in accordance to procedures.
• Collect and analyze data and generate reports.
• Support development of project documentation (FMEAs, specifications, plans).
• Participate in technical reviews.
• Support change control processes through assessment of system changes and identifying the extent of qualification or re-qualification activities as needed.
• Maintain configuration management documentation and support instrument prototype builds.
• Support instrument, PCB, and firmware troubleshooting and issue resolution.
• Continuously improve and update the validation program.
• Comply with the design control guidelines and Quality requirements within the company's regulated ISO\ FDA environment.

Education, Training, and Experience

B.S. in an Engineering discipline with 5+ years of engineering experience or M.S. in an Engineering discipline with 3+ years of engineering experience. Medical Device field is a plus.

Other Skills and Abilities

• Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation.
• Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures.
• Experience with engineering design documentation such as drawings and schematics.
• Strong troubleshooting skills.
• Systems Engineering and integration skills with demonstrated relevant experience over the full product development cycle for a complex electromechanical system.
• Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new verification and validation methodologies.
• Knowledge of electro/mechanical production processes.
• Technical skills in the relevant Manufacturing Engineering disciplines.
• Knowledge of FDA, QSR and ISO quality systems.
• Strong collaborative and communication skills.
• Exceptional attention to detail.

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