Technical Program Director - Germantown - Senseonics, Incorporated

    Senseonics, Incorporated
    Senseonics, Incorporated Germantown

    2 weeks ago

    Description

    The Technical Program Director will lead complex Medical Device development programs from concept to commercialization, focusing on technical execution, quality, risk management, and regulatory compliance, while managing budgets, timelines, and stakeholders to deliver innovative, safe, and effective devices. This role will bridge engineering, clinical, and business needs, ensuring seamless integration of hardware, software, algorithms, and driving best practices in project execution. The individual should be self-driven and work cross functionally collaboratively with Marketing, Sales, Clinical, Quality and Regulatory organizations in delivering program goals.

    This role will be responsible for leading development of the next generation implantable Continuous Glucose Monitoring (CGM) system through commercialization.

    Duties and Responsibilities include, but are not limited to:

    • Program Leadership: Provide technical and strategic direction for large programs across broad functional disciplines. Work with all Project team members throughout the development in order to ensure that products are produced in a safe, efficacious and quality while keeping within established time frames
    • Project Management: Oversee planning, scheduling, resource allocation, risk mitigation, and execution working collaboratively with internal cross functional teams and external partners. Exercises wide latitude in determining objectives and approaches to critical assignments. Overall accountability of all program level development activities which may include leading, participating or supporting all phases.
    • Quality & Regulatory Compliance: Ensure adherence to Quality Management System, design controls, and regulatory standards.
    • Cross-Functional Collaboration: Partner with R&D, Clinical, Regulatory, Manufacturing, and Quality teams, resolving issues and driving integration.
    • Stakeholder Management: Communicate progress, manage scope changes, and report to executive leadership through a regular cadence of forums.
    • Technical Oversight: Lead directly or indirectly, root cause analysis, technical problem-solving, and integration of complex system-level components (hardware, software, firmware).
    • Mentorship: Strong mentor to direct and in-direct reports
    • Vendor Management: Broad experience and ability to work with and manage external partners and their deliveries

    Knowledge, Skills, Abilities and Requirements:

    • BS/MS/PhD in Engineering (MechE, EE, ChemE, Biomedical or similar fields) from an accredited university
    • 10+ years in Implantable Medical Device product development, with 5+ years in program/project management specifically working with Product Development, Process Development and Manufacturing.
    • Deep understanding of the full product lifecycle, risk management, Agile/Scrum, JIRA, ISO 13485, 21 CFR Part 820, and experience with medical device software/hardware. Good understanding of regulated product development
    • Excellent knowledge of documentation and process needs to meet FDA and CE regulatory requirements
    • Experience in managing projects from inception to post-market.
    • Must have strong analytical skills to analyze dependencies in a project and be able to proactively understand/anticipate the critical paths on projects
    • Ability and willingness to travel frequently (25–50%)

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  • Work in company

    Technical Program Director

    Only for registered members

    The Technical Program Director will lead complex Medical Device development programs from concept to commercialization, focusing on technical execution, quality, risk management, and regulatory compliance. · Provide technical and strategic direction for large programs across broa ...

    Germantown

    1 month ago

  • Work in company

    Technical Program Director

    Only for registered members

    The Technical Program Director will lead complex Medical Device development programs from concept to commercialization, · technical execution · quality · risk management · regulatory compliance · ...

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