Validation and Verification Engineer

• Low-cost medical, dental, and vision benefits starting day one
• 11 paid holidays
• 160 hours of paid time off
• Annual bonus
• 9.5% 401k company contribution with no vesting period
• Tuition reimbursement up to $10000 per calendar year
• Onsite cafeteria with daily food stipend

• 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.

• 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.

#LI-US