Project Manager-Medical Devices

Rx Bandz is seeking an experienced Project Manager who is energetic, innovative, detail-oriented, to own project execution, milestone delivery, and financial alignment across our medtech product portfolio. Partnering with the CEO, CTO, and CFO, you will bridges operations and finance, ensuring that project timing, deliverables, and budgets stay tightly aligned with company forecasts and government contract commitments,

We’re looking for a take-charge person who loves managing Gantt charts and other project management tools and budgets, with clear and concise communication skills. We need someone who takes ownership of the projects. You’ll be learning and growing professionally from day one. 

Role Overview:

The Project Manager owns end to end delivery across our grant and government contract portfolio. This includes building and maintaining the integrated project schedule, owning milestone tracking and contract deliverables, partnering with the CFO on budget vs forecast variance reporting, and serving as the central point of accountability for on time, on budget execution. We are looking for an experienced project leader who is fluent in Gantt charts, project management tools, government contract reporting (CDRL, IMS), and budget management, and who can operate with minimal supervision while keeping the executive team informed.

Salary: 80,000-100,000, commensurate with experience

Key Responsibilities:

• Grants/Contracts Administration & Compliance:
• Manage the full lifecycle of grant activities, including coordinating submissions, tracking applications as well as awarded grant/contract reporting deadlines, and supporting compliance requirements. Establish, monitor, and report on critical contract milestones including design reviews, prototype deliveries, testing phases, and production readiness. Maintain detailed milestone tracking systems, forms and dashboards for internal and government stakeholders to ensure timely completion of milestones. Maintain and track all agreements and organizational documentation for collaboration contracts, ensuring proper execution, compliance, and renewal tracking. Experience with military contracts and reporting is a plus.
• Reporting & Regulatory Filings:
• Oversee preparation and submission of corporate and grant-related reports, and reporting obligations tied to grants, contracts, and collaborations. Familiarity with medical device regulations is preferred
• Financial Forecast Alignment & Budget Management:
• Partner with the CFO to own monthly project budget vs forecast variance reporting. Tie contract milestones to the revenue recognition schedule and cash flow forecast. Flag burn rate deviations greater than 10% within five business days. Collaborate with external financial partners to ensure timely and accurate monthly reporting, including tracking and managing contract budgets. Identify and improve processes to reduce costs.
• Operational Systems & Project Tracking:
• Maintain internal systems including Google Workspace and project tracking tools to ensure organization, visibility, and alignment across initiatives.
• Communication 

Update Team with frequent updates including meeting minutes, budgeted, schedules/timelines 

About Rx Bandz:

Company

Rx Bandz is a dynamic, fast-paced company that is developing the next generation of compact and patient centric auto-injectors. We are advancing the world of health by improving patient quality of life. We make giving lifesaving injectable medications simple for anyone, anytime, anywhere. We are a highly cross-functional group of extremely passionate employees; every perspective is encouraged and individuals driving toward solutions is expected. 

Requirements

• Bachelor’s degree in business administration, life sciences, or a related field preferred
• 5 to 8 years of experience in project management, program management, or operations within biotech, medtech, or life sciences. Direct experience reporting project budget and forecast variance to senior finance leadership is strongly preferred.
• Familiarity with military contracting compliance requirements strongly preferred
• Experience in medical devices, preferred
• PMP, PgMP, or equivalent project management certification required or in active progress
• Strong organizational and project management skills with iron=clad attention to detail
• Experience with financial systems
• Ability to manage multiple priorities and deadlines in a fast-paced environment
• Excellent communication and coordination skills
• Experience working with contracts and research-related agreements is a plus

Project Leadership & Execution

• Develop and manage multiple concurrent auto-injector development projects from concept through production and delivery, budgets, ensuring on-time, on-budget completion
• Responsible for tracking, monitoring and managing project expenses work hours, as appropriate
• Manage the project per the quote/contract, design and development plan and/or other project documents.
• Identify and manage external contractors and suppliers to ensure completion of projects per the agreed upon milestones and within budget.
• Coordinate with government contracting officers, program managers, and military stakeholders

Milestone Tracking & Contract Performance

• Establish, monitor, and report on critical contract milestones including design reviews, prototype deliveries, testing phases, and production readiness
• Maintain detailed milestone tracking systems, forms and dashboards for internal and government stakeholders
• Identify potential milestone delays early and implement corrective action plans
• Prepare and submit Contract Data Requirements List (CDRL) deliverables on schedule
• Manage Integrated Master Schedule (IMS) and Earned Value Management (EVM) reporting
• Coordinate Gate Reviews and milestone decision points with government customers
• Track and report Key Performance Indicators (KPIs) and contract metrics

Financial Management

• Track and manage budget performance with the CFO
• Identify and improve processes to reduce costs (as identified)

Regulatory & Compliance Management

• Coordinating with Regulatory Affairs, ensure compliance with FDA regulations for combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485)
• Manage design control processes and documentation per medical device quality systems
• Maintain adherence to DFARS, ITAR and export control requirements

Contract & Stakeholder Management

• Serve as primary point of contact for military customers and government agencies
• Manage and report contract deliverables, milestones, and reporting requirements, including progress meetings with stakeholders
• Conduct Monthly Program Reviews (MPRs) and Quarterly Business Reviews (QBRs)

Risk & Quality Management

• Identify, assess, and mitigate project risks proactively
• Ensure product development follows risk management standards (ISO 14971)
• Drive continuous improvement initiatives and lessons learned processes

Required Qualifications

• Minimum 5 to 8 years of qualified business management experience in the areas of project management, financial management, and human resource management.
• Preference for 2 years of experience with government or military contracts
• Preference for experience with medical device (auto-injector) development or manufacturing
• PMP certification required or in active progress

Technical Knowledge

• Expertise in successful management of complex projects
• Deep understanding of FDA combination product regulations and ISO 13485 (preferred)
• Experience with auto-injector technology including spring mechanisms, needle safety systems, and dose delivery mechanisms and platforms (preferred)
• Familiarity with FAR/DFARS and government contracting processes (preferred)
• Knowledge of military medical countermeasures and battlefield medicine requirements, DoD procurement
• Knowledge of design controls, verification/validation protocols, and regulatory submissions (510(k), PMA, NDA) (preferred)
• Add code 5733 to your resume or cover letter

Skills & Competencies

• Proven track record managing complex, multi-disciplinary projects with budgets between $1M and $5M
• Expertise in milestone planning, tracking, and reporting using government contract management systems
• Strong leadership and team management capabilities
• Excellent written and verbal communication skills for technical and non-technical audiences
• Proficiency with project management tools and milestone tracking software
• Experience with Earned Value Management Systems (EVMS)

Physical Requirements

• Mostly sedentary work. The ability to stand, sit and walk for at least 4 hours at a time
• The ability to lift 15 pounds on occasion
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions
• Ability to work effectively and collaboratively in high stress environment.

Work Environment

• Office and manufacturing environment with occasional travel 
• May require availability for government audits, inspections, and emergency response situations
• Ability to work effectively and collaboratively in high stress, fast-paced environment

Personal Attributes

• Self-starter with strong problem-solving skills and willingness to learn
• Excellent written and verbal communication abilities
• Team player who collaborates effectively across functions
• Organized and detail-oriented with strong time management skills, work error-free
• Adaptable and able to work in a fast-paced environment
• Professional demeanor for agency interactions

What We Offer

• Mentorship from senior regulatory professionals
• Exposure to diverse combination product modalities and regulatory pathways
• Professional development and training opportunities
• Collaborative culture working on innovative medical technologies

Rx Bandz is an Equal Opportunity Employer and maintains a drug-free workplace. Candidates must be eligible to work in the United States, pass background checks, and be able to obtain appropriate security clearances.