Project Systems Test Engineer - Patient Interface

Job Title
Project Systems Test Engineer - Patient Interface

Job Description

The Project Systems Test Engineer will play a critical role in improving and saving lives around the world by coordinating all Systems Test activities necessary to support the release, relaunch, and maintenance of Patient Interface Devices (Masks), used for the treatment of Obstructive Sleep Apnea.

Your role:

• Will work as a Systems Test Lead to coordinate all Systems Test activities necessary to support the release, relaunch, and maintenance of FDA-regulated Patient Interface Devices (Masks).
• Will assess and test requirements at the part, sub-system, and system levels.
• Develop Systems Test plans, test procedures, requirements trace matrices, and test reports.
• Perform regression analysis and determine testing associated with design changes.
• Plan and facilitate Systems Test formal technical review and design review meetings.
• Project Leadership/Support: For multiple/concurrent projects, will: Estimate resource needs for project support, assign project tasks and responsibilities, provide weekly project status reports, Act as advisor to team to meet schedules/solve technical problems and Prioritize project tasks to complete on schedule while maintaining quality of work.
• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Review requirements and scrutinize for testability.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate novel test methods (TMV, DOE, Gage R&R studies).
• Will personally execute test procedures and utilize test technicians.
• Participate in defect review boards, Log defects and issues found during Systems Test activities and track to closure.
• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Reporting to the Senior Manager-R&D Hardware Wearables & PI, you will collaborate with a cross functional team of engineers and specialists throughout the Sleep & Respiratory Care organization.
• This Hybrid , Pittsburgh, PA based role may require travel up to 10%.

• You have a minimum of 5 years' experience in Systems Test Engineering for FDA regulated medical devices, experience in patient-worn medical products highly preferred.
• You have proven experience developing Systems Test plans/procedures, requirements trace matrices, and test reports.
• You have strong experience using automated test tools, specialty test equipment and developing/validating test methods (TMV, DOE, Gage R&R).
• You have working knowledge of global medical device regulations, requirements, and standards- (EUMDR, ISO 13485/14971/10993/18562 ,17510-2015)
• You have a minimum of a Bachelor's degree in Engineering- Mechanical, Bioengineering, or Plastics (REQUIRED). Master's Degree (desired).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position . US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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