LOC: Monroeville, PA (Pittsburgh area)
LOA: 6+ months
* Need last 4 of SS# and DOB to submit
Preferred Software – Test Director/ALM, DOORs Description – Seeking a Cleaning and Disinfection Test Engineer. The selected candidate will work under direct supervision of the Test Lead to produce clear and concise documents for medical devices, perform associated testing, and report findings. Job duties include, but are not limited to:
• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Develop C&D test plans, test procedures, and test reports.
• Review requirements and scrutinize for testability.
• Communicate and coordinate testing with internal and external test labs.
• Execute test procedures both personally and using test technicians.
• Log defects and issues found during C&D activities and track to closure.
• Perform regression analysis and determine testing associated with design changes.
• Provide weekly project status reports.
• Prioritize project tasks to complete on schedule while maintaining quality of work.
• Assess failures and coordinate corrective actions with project teams.
• Review product requirements with development teams to ensure that they are complete and testable.
• Coordinate C&D Formal Technical Reviews with cross functional group to plan and execute strategies.
• Interact with Technical Writers to ensure product labeling complies with executed test procedures.
• Bachelor’s Degree in engineering discipline or equivalent unless otherwise specified.
• Knowledge of electrical, mechanical principle is desired.
• 1-3 years professional experience.
• Basic understanding of FDA, EU MDR and Spectaris C&D guidance, along with global medical device regulations, requirements, and standards preferred.
• Strong written and verbal communications skills
• Working knowledge of test management tools and frameworks (ALM, DOORS)
• Experience using test instrumentation and equipment in and out of a Lab environment.
• Strong commitment to quality and aptitude to understand regulations and compliance standards.
• Knowledge of biological testing that supports the assessments of C&D evaluations.