Technical Program Director

Senseonics, Incorporated; Germantown (MD); On-site; USD 130,000 - 160,000; Full time

Job summary

A leading medical device company in Maryland is seeking a Technical Program Director to lead the development of innovative implantable Continuous Glucose Monitoring systems. The ideal candidate will manage complex programs from concept to commercialization, ensuring technical execution and regulatory compliance. With over 10 years in medical device development and strong project management skills, you will guide cross-functional collaboration and deliver high-quality products. Ability to travel frequently is required.

Qualifications

• 10+ years in Implantable Medical Device product development.
• 5+ years in program/project management with Product Development and Manufacturing.
• Deep understanding of product lifecycle and risk management.

Responsibilities

• Lead technical programs across disciplines and ensure quality production.
• Oversee planning, scheduling, and execution with internal teams.
• Ensure adherence to Quality Management Systems and regulatory standards.
• Partner with R&D and other teams to drive integration and resolve issues.

Skills

Program Leadership

Project Management

Quality & Regulatory Compliance

Cross-Functional Collaboration

Technical Oversight

Mentorship

Vendor Management

Analytical Skills

Education

BS/MS/PhD in Engineering (MechE, EE, ChemE, Biomedical or similar fields)

Tools

JIRA

ISO 13485

21 CFR Part 820

Job 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%)