What are the responsibilities and job description for the Senior Project Manager position at NIRSense Inc?
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About the Company:
NIRSense is a cardiology monitoring company focused on developing world-leading noninvasive medical systems. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a small, dedicated team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of stakeholders who are driven to transform the way humans understand and interact with their own health.
Job Summary:
NIRSense is seeking an experienced Senior Project Manager to work alongside our growing engineering and scientific team in its Morrisville, NC, office. The ideal candidate will be an experienced Project Manager who leads cross-functional medical device development projects with a strong emphasis on FDA Design Controls, ISO 13485 compliance, and risk management principles (ISO 14971). This individual will be responsible for driving project execution from concept through design transfer, ensuring documentation rigor, regulatory readiness, and on-time delivery of high-quality, compliant products. This person will coordinate multiple ongoing research prototypes, product development, and system evaluation projects for NIRSense’s many customers. They will integrate with a team of researchers, engineers, technicians, and scientists to deliver various product designs.
Key Responsibilities:
- Lead cross-functional project teams through concept development, design, verification/validation, and transfer to manufacturing
- Develop and maintain clear project plans, timelines, budgets, and resource forecasts aligned with company priorities
- Partner closely with engineering leads and technical experts to identify risks, dependencies, and trade-offs early
- Coordinate activities across R&D (electrical, firmware, software), Quality, and Regulatory to ensure design documentation meets compliance standards
- Facilitate design reviews, manage project change control, and ensure deliverables meet quality expectations on time.
- Serve as the central point of communication between leadership, engineers, and external partners
- Establish and continuously improve project management governance, such as processes, templates, and tools, appropriate for a growing R&D organization
- Track and communicate project metrics (milestone progress, budget adherence, risk exposure) to project teams, functional leads, and leadership
- Contribute to strategic discussions on product roadmap, resourcing, and prioritization
- Drive project deliverables from R&D and product development to manufacturing transfer
- Foster a collaborative, accountable, and innovation-driven culture across engineering teams
Education & Required Qualifications:
- Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical field
- Minimum 5–10 years of experience managing engineering or product development projects in medical devices or regulated healthcare
- Strong working knowledge of FDA Design Controls for 510K submissions, ISO 13485, and risk management principles
- Demonstrated ability to manage multiple concurrent projects in a fast-paced R&D environment
- Hands-on experience with early-stage prototyping, verification/validation, design transfer, and risk management.
- Proficiency in project management and collaboration tools (e.g., MS Project, ClickUp, Confluence, etc.)
- Excellent organizational, communication, and stakeholder management skills
- Proven ability to lead without layers of hierarchy — driving accountability, alignment, and progress across small teams
Preferred Qualifications
- Master’s degree (MS, MBA, or equivalent) in Engineering, Business, or related field
- PMP certification
- Strong experience working in a Quality System (QS) Regulation under 21 CFR 820 and ISO 13485 QMS.
- Experience working with contract manufacturers, R&D partners, or academic collaborators
- Familiarity with electromechanical systems, embedded software, or sensors
- Experience developing and implementing phase-gate or lightweight project frameworks suitable for smaller organizations
- Demonstrated success in building repeatable processes or infrastructure to scale R&D operations
- Strong business acumen and the ability to balance technical rigor with commercialization goals