FDA Software Development Manager

FDA, Medical Device, SDLC
Contract W2, 12 Months
Depends on Experience
Work from home available

Job Description

  • Our client in Oakland, CA is seeking a Program Manager for a long-term contract position.  This exciting role will have you working on advanced R&D SW product development in the medical device industry.  With a high level of independence, coordinate activities to support new product launch or launches and/or upgrades to existing products.  The Program Manager should have experience in medical software product development with experience dealing with the regulatory, quality and safety aspects, plus experience and thorough understanding of the software development process required by FDA.

    Responsibilities include:

    • Strategic Develop: Product requirements and programs to meet strategic needs of the business. This position is responsible for the product definition and development, and preparation of all departments for a successful timely launch of a quality product meeting the business and product strategies.
    • Communicate product development program status to development teams and company management. This position is highly visible and accountable, responsible for directing, and reporting to senior management, the activities in the launch for a new product.
    • Coordinate activities between operational and commercial organizations from project initiation through launch. This position will provide leadership to a project team, integrating activities across all departments, with influence across departmental lines.
    • Tactical Hold: Regular project review meetings to coordinate and document the activities of all departments contributing to a product launch, including QA/RA, Marketing, R&D, Commercial, and Finance.
    • Generate and control project documentation to meet design control requirements, such as product specification, Design and Development plans, product configuration, test plans and protocols, design and test reports, risk analysis, data privacy analysis, etc. 
    • Generate product documentation such as EULA, privacy notice, user documentation, etc.
    • Develop product cost/budget estimates working with R&D and Finance.   Manage program costs including generating and managing purchase orders.
    • Regulatory: Responsible for implementing and maintaining the effectiveness of the quality system in an FDA regulated environment.


    • Bachelor’s degree or higher in computer science, information technology or related field, or business degree with applicable experience.
    • Evidence of continuing education, such as technical certifications, a plus
    • Experience working in an FDA regulated industry (SW development) is required.
    • Experience developing software products and thorough understanding of the software development process.
    • Minimum 7 years’ experience.
    • Knowledge of Program Management tools such as project scheduling, work breakdown structures, time and cost reporting is required. 
    • Local to the Bay Area preferred.  Work will be remote during COVID lockdown.
Dice Id : 10112459
Position Id : 6925169
Originally Posted : 3 weeks ago
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