Aventusoft is a very well-funded MedTech company developing cardiovascular diagnosis and monitoring technologies. With a mission to make high-value cardiac assessments more affordable and accessible. We are a very local company with deep roots in Florida, but our recognitions have been national and international. We are an Inc. fastest-growing regional company 2023 and 2024, BioFlorida winner 2023, GrowFL company to watch recognition in 2020, and have won the prestigious department of defense innovation awards (2018, 2019, 2020, 2022, 2023), with being showcased as a success story company by DARPA.

We are seeking a dynamic and experienced Project Manager to lead the project activities throughout all phases of the project life cycle and launch of our flagship medical device, and digital health products. This role is critical in shaping the future of healthcare technology and improving patient outcomes through innovative solutions.

Joining Aventusoft means becoming part of a team dedicated to making a tangible impact on patient care through technological innovation. We offer a collaborative work environment, opportunities for professional growth, and the chance to be at the forefront of healthcare advancements.

Responsibilities

Lead and coordinate the project for the successful development, testing, launch of products and after sales support activities.
Responsible for coordinating, tracking and ensuring successful completion of project activities including new requirement capture (voice of the customer), manufacturing and ship acceptance activities to meet quality, schedule and budget goals required for a successful product launch.
Develop and manage comprehensive project plans, ensuring timely completion of milestones and adherence to budget constraints, with the understanding of the master schedule and track each team member's deliverables.
Collaborate closely with cross-functional teams including, engineering, quality, regulatory, clinical, marketing, and sales to align project objectives with company strategy.
Oversee project risk management processes, identifying potential challenges, proactively devising mitigation strategies and be able to work with individual team members to resolve issues and close gaps.
Facilitate effective communication across all levels of the project, ensuring transparency and stakeholder engagement.
Ensure the project complies with industry standards, FDA regulations and design controls pertinent to medical devices and technology.
Monitor and report on project progress to both internal and external stakeholders.
Drive internal & customer deliverables from initial presentation, to quote, to contract, and after sales support.
Identify and collect customer specific requirements.
Track logistics for medical device inbound and outbound shipping.
Manage training materials for customers.
Develop Project Charter and Business Case for each project.
Negotiate and agree on resource scheduling with stakeholders.
Develop and execute Communications Plan for internal/external stakeholders to ensure clear visibility to project progress.
Ensure Project Quality is maintained to the highest standard.
Schedule and chair quarterly reviews.
Adhere to all company policies and procedures.

Qualifications

BSCS/EE/BME with 5+ years’ experience in product management with extensive project management responsibility. MS preferred.
3-5 years’ experience in an FDA regulated medical device/healthcare industry.
Project Management Professional Certification from the Project Management Institute preferred.
Proven experience in project management, preferably in the medical device or healthcare technology sector.
Excellent organizational, communication, and problem-solving abilities.
Familiarity with project management tools and methodologies (e.g., Agile, Scrum, PMBOK).
Knowledge of medical device regulations and compliance standards (e.g., FDA, CE Marking).
New product commercialization experience in the medical device/healthcare industry.
Ability to work in a fast-paced and dynamic start-up environment.
Project experience working with FDA regulatory, 510k clearance preferred

Job Type

Only open to candidates who can commute daily to work location in Boca Raton, FL.
Full-time
One location (Boca Raton, FL) and no relocation will be provided.

Experience

Project management: 5+ years
Medical Devices/Digital Health: 3+ years

What's in it for you

Huge room for growth!
Strong base salary!
Annual bonus!
Stock!
Healthcare benefits!
Un-limited PTO/VACATION!
SIMPLE IRA (with match!)
Gym reimbursement!
Amazing company culture!
Opportunity to drive successful teams within an exciting industry!

Aventusoft LLC

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Project Manager – Medical devices and Digital Health