Bausch Health

  • Principal Engineer (R&D - Systems)

    Job Location US-WA-Bothell
    Job ID
    11213
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Principal System Engineer confirms Solta products meet functional system requirements, coordinates activities involved in system level specification, testing, and development for medical device products in the aesthetic space. The applicant must be a hands-on self-starter, who has the ability to work collaboratively with a multi-disciplinary product development team in accordance with the standards IEC 62304, IEC 62366, IEC 60601, and ISO 13485.

    Responsibilities

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

    • Formulate and manage system functional requirement specifications, risk management and risk assessments.
    • Establish and maintain product requirements trace management via DOORS NG database tool.
    • Ensure traceability of verification tests to product functional requirements.
    • Participate in defect issue tracking and resolution.
    • Work closely with other departments to ensure projects conform to all regulatory and quality regulations.
    • Organize, plan, lead and manage system engineering activities in alignment with project goals.
    • 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.
    • 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

    Experience, Education, Training, Traits:

     

    • 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 and proven track record of successful leadership with system engineering projects
    • Experience with preclinical and clinical studies and evaluations
    • Working knowledge of 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 management
    • Ability to focus on and achieve scheduled milestones, including contingency planning.
    • 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/-2, 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/-2
    • 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 peers, managers, executives, system users, and suppliers. 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, as well as 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 and may also involve daily keyboard data entry. Duties of this job could include standing and/or walking for extended periods of time. 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.

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