Principal Engineer (WA)
Apply NowCompany: Bausch Health Companies
Location: Bothell, WA 98012
Description:
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. 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 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, ISO13485, FDA and other requirements, identifying and developing test methods and individual test cases across multiple products; writing test protocols for software or hardware verification and performing hands on trouble shooting of test failures, as necessary.
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 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 trace management via DOORS NG database tool.
Provide technical leadership in applicable test methods of the products.
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
Ensure traceability of verification tests to product functional requirements.
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 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.
Experience, Education, Training, Traits:
BS or MS in Engineering plus 10 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.
Proven track record of successful product testing and validation using a variety of testing tools and techniques.
Working knowledge of project planning and management including use of PM 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: with C++, C#, Visual Basic, or Matlab.
Use of defect tracking tools such as TestTrack, 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, ISO13485.
Risk Management techniques and experience in EN 14971:, EN IEC 60601-1:, EN IEC 62304: Medical Device Directive Essential Requirements.
Experience in Usability Engineering compliant to EN IEC 62366:.
Experience producing designs compliant to EN IEC 60601-1:
Working experience with ESD environment.
Strong team collaboration and communication skills.
Driven to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
Demonstrated ability to multi-task.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $115k to 173k per year.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Job Offer Fraud Statement.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. 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 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, ISO13485, FDA and other requirements, identifying and developing test methods and individual test cases across multiple products; writing test protocols for software or hardware verification and performing hands on trouble shooting of test failures, as necessary.
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 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 trace management via DOORS NG database tool.
Provide technical leadership in applicable test methods of the products.
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
Ensure traceability of verification tests to product functional requirements.
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 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.
Experience, Education, Training, Traits:
BS or MS in Engineering plus 10 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.
Proven track record of successful product testing and validation using a variety of testing tools and techniques.
Working knowledge of project planning and management including use of PM 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: with C++, C#, Visual Basic, or Matlab.
Use of defect tracking tools such as TestTrack, 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, ISO13485.
Risk Management techniques and experience in EN 14971:, EN IEC 60601-1:, EN IEC 62304: Medical Device Directive Essential Requirements.
Experience in Usability Engineering compliant to EN IEC 62366:.
Experience producing designs compliant to EN IEC 60601-1:
Working experience with ESD environment.
Strong team collaboration and communication skills.
Driven to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
Demonstrated ability to multi-task.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $115k to 173k per year.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Job Offer Fraud Statement.