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    Senior Software Validation Engineer - Houston, United States - Acumed

    Acumed
    Acumed Houston, United States

    3 weeks ago

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    Description
    Acumed LLC


    Come join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.


    Job Scope:


    The Senior Software Validation Engineer is responsible for computer software assurance for automated systems used as part of medical device production or the organization's quality system in accordance with FDA Quality Systems Regulation, ISO 13485 and other applicable country specific regulations.

    The Senior Software Validation Engineer participates and provides guidance to the organization and ensures software-related projects are developed, tested and delivered according to established procedures that will assure that they meet all quality requirements.


    Responsibilities:
    Provides training, guidance, and interpretation on regulations, procedures, and requirements related to computer software assurance.
    Ensure the organization's software assurance program complies with all regulatory requirements and reflects current industry practices.
    Monitor and audit all aspects of software implementation including development, configuration management, verification and validation, and transition to production.
    Provide guidance and support regarding assurance activities including unscripted testing and scripted testing.

    Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach.

    Reviews and approves software validation protocols and reports; develops and executes strategies to close gaps in an efficient, technical, and compliant manner.

    Provides management with status updates on assigned responsibilities/goals and escalates issues as needed.
    Writes and updates controlled documents in Windchill related to the maintenance of the organization's software assurance program.
    Serves on cross functional teams that support or are implementing software at the organization.


    Qualifications:


    Bachelor's degree in an engineering or science discipline; 5+ years directly applicable experience can be used in lieu of the degree.

    5+ years of experience in software assurance (or related activities) in a regulated environment. If not degreed requires 11 years of experience in software assurance in a regulated environment.
    Direct experience working in the medical device industry preferred.

    5+ years of experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.).

    Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
    Proven track record of strong teamwork and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
    Working knowledge of ERP Systems (SAP preferred) and Microsoft Office. Expert at Microsoft Excel. Solid experience with Minitab.
    ASQ Certified Quality Engineer preferred.
    Demonstrated leadership/mentoring skills.
    Adaptable to fast paced, dynamic work environments.

    Target Compensation:
    $104,694.96 – $127,960.50 salary + bonus.

    Benefits:
    Medical, Dental and Vision insurance, 401k matching, + more


    Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.


    We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class.

    If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.

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