Valeant Pharmaceuticals

  • Principal Engineer, Systems

    Location US-WA-Bothell
    Job ID
    10163
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    The Principal System 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 & usability 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.

     

    Responsibilities

    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 and usability 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.

    Qualifications

    • BS or MS in Engineering plus 5 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.
    • Experience with usability engineering and testing processes
    • Experience with preclinical and clinical studies and evaluations
    • Previous Biomedical experience is a plus
    • 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, ISO13485:2003.
    • 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.

     

    Language and Verbal Skills

    Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, test plans / protocols and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.

     

    Math Skills

    Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to use basic engineering tools to perform calculations and simulations and interpret project results/data.

     

    Analytical and Reading Skills

    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.  Ability to read technical and clinical literature and documents and extract important concepts.

     

    Physical Requirements

    While performing the duties of this job, the employee may be required to perform lifting tasks of up to 10 pounds for short durations.  The employee will be required to use a computer for up to 8 hours consecutively Duties of this job may involve standing and/or walking for extended periods of time.  Duties also involve daily keyboard data entry.  Specific vision abilities required by this job include close vision and color vision.

     

    Work Environment

    The noise level in the work environment is usually moderate. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.

     

    Safety

    Solta is committed to the health and safety of our employees.   We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

     

    Be Aware of Recruiting Fraud

    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 Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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