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Senseonics, Incorporated · 1 day ago

Technical Program Director

Germantown, MD

Full-time

Onsite

Director/Executive

10+ years exp

Senseonics, Incorporated is seeking a Technical Program Director to lead complex Medical Device development programs from concept to commercialization. The role focuses on technical execution, quality, risk management, and regulatory compliance while managing budgets, timelines, and stakeholders to deliver innovative and effective devices.

BiotechnologyHealth CareMedicalMedical DeviceSensorWearables

Hiring Manager

Hari Sree

Responsibilities

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

Qualification

Implantable Medical Device developmentProgram/Project ManagementRisk ManagementRegulatory ComplianceAgile/ScrumISO 1348521 CFR Part 820Stakeholder ManagementVendor ManagementAnalytical SkillsCross-Functional CollaborationMentorship

Required

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