Principal Systems​/Verification Engineer; Aesthetic Med Device; Bothell, WA

Position: Principal Systems/Verification Engineer (Aesthetic Med Device) (Bothell, WA)
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact.

The Principal Systems/Verification Engineer confirms Solta products meet functional system requirements. The applicant must be a hands-on self-starter, who has the ability to work collaboratively with a multi-disciplinary product development team in support of all aspects of component and systems level verification testing of medical devices. This person will develop and manage component and system level testing consistent with product system requirements in accordance with the Company, applicable standards (e.g. IEC
14971, IEC
60601, & ISO
13485), FDA and other requirements, identifying and developing test methods and individual test cases across multiple products;

Principle

Responsibilities and Duties:

Note:

The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

* Develop System/SW verification Tests using C, C++ and C#

* Develop tests for device software, including automated tests.

* Lead / participate in Design and Code reviews

* Demonstrated experience with Medical Device System/SW verification for Windows CE based devices and Embedded Linux based devices.

* Coordinate / conduct Design Verification testing (embedded Linux / C#)

* Provide technical leadership / mentoring - especially in applicable test methods of products

* Develop plans and coordinate activities for system level verification testing, including regression analysis of system functionality to determine scope of testing, overseeing test execution and reviewing individual test results and data for inclusion with test reports.

* Write individual and summary level test reports which provide clear and concise results along with appropriate detail information as needed.

* In partnership with other system engineers, formulate system functional requirement specifications and risk assessments.

* Establish and maintain product requirements and verification trace management via a requirements management tool.

* Identify test cases and write verification test protocols for software and hardware verification/validation that utilize manual and automated test methods.

* Design and/or develop verification scripts to utilize automated test methods

* Develop verification test scripts and protocols utilizing automated and manual test methods.

* Address and analyze functionality and performance related issues discovered during verification testing.

* Document results of work activities.

* Participate in defect issue tracking, troubleshooting, and resolution.

* Identify and isolate product defects, perform root cause analysis, and work with engineering team across design disciplines to determine corrective action.

* Work closely with other departments to ensure projects conform to all regulatory and quality regulations.

* Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.

* Be willing to travel occasionally for short duration trips

Qualifications:

* BS or MS in Engineering plus ten years of experience designing / validating / testing of complex electro-mechanical systems, and at least five years in medical devices or closely related field.

* Knowledge / experience in System Engineering concepts/principles.

* Experience with C# and .NET desired

* Verification experience with embedded platforms including Windows CE and Embedded Linux desired

* Proven track record of successful product testing, verification, and validation using a variety of testing tools and techniques.

* Ability and willingness to support project planning and management including use of scheduling software such as MS Project.

* Demonstrated experience on the use of a requirements management tool (e.g. DOORS/DOORS NG) for requirements trace management

* Ability to focus on and achieve scheduled milestones, including contingency planning.

* Ability to operate test equipment such as oscilloscope, logic analyzer, etc.

* Competency in at least one of the following: C++, C#, Visual Basic, or Matlab.

* Use of defect tracking tools such as Test Track, JIRA, etc.

* Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.

* Regulatory experience in QSR, ISO
13485.

* Risk Management techniques and experience in EN 14971:,

* Experience in Usability Engineering compliant to EN IEC 62366:.

* Experience producing designs compliant to EN IEC 60601-1 /-2:, EN IEC 62304:
Medical Device Directive Essential Requirements.

Working experience with ESD environment.

* Strong team collaboration and communication skills.

* Driven to get the job done in the face of…