Principal Engineer/Manager, Research & Development - MN

FloodGate Medical•Tampa, FL

About The Position

VentureMed Group is a pioneering medical device company focused on developing endovascular solutions for treating peripheral arterial disease (PAD) and stenoses in arteriovenous (AV) fistulas and grafts. Their flagship FLEX Vessel Prep™ System uses a non-balloon, micro-incision technology to optimize vessel preparation and improve outcomes when combined with revascularization therapies. With recent regulatory milestones and expanded clinical evidence, VentureMed is scaling its commercial footprint while reinforcing its commitment to better patient outcomes. Why You Should Join Us This is a Principal Engineer/Manager, R&D role in Minnesota . The Principal Engineer/Manager of Research & Development is responsible for executing product development activities within the company’s medical device portfolio, including the Venous platform. This individual will lead efforts related to design controls, product verification and validation, and sustaining engineering to ensure products meet performance, safety, and regulatory requirements. The role requires a hands-on engineer who can manage projects, collaborate across departments, and drive continuous improvement from concept through commercialization.

Requirements

Bachelor’s degree in chemical, mechanical or Biomedical Engineering, or related discipline.
Minimum of 10 years of experience in medical device product development, including at least 5 years working under design controls.
Demonstrated knowledge of design control principles per 21 CFR 820 and ISO 13485 standards.
Experience leading verification and validation testing and compiling documentation for regulatory submissions.
Strong understanding of medical device manufacturing processes and design-for-manufacturability principles.
Proven track record managing multiple development projects from concept through design transfer.
Hands-on experience in device design, prototyping, test method development, and 3D printing.
Excellence in problem-solving and root cause investigations.
Previous ownership of design history file with experience producing all requisite documents including plans, protocols, reports, design specifications, traceability matrices, test methods, and build instructions.
Excellent written and verbal communication skills, with ability to lead technical discussions and prepare detailed documentation.
Highly organized, self-motivated, and detail-oriented professional capable of working both independently and collaboratively.
Ability to travel up to ~20%.

Nice To Haves

Experience in a 3D-modelling software preferred.

Responsibilities

Plan and execute product development activities, ensuring adherence to design control processes in compliance with FDA and ISO 13485 requirements.
Prepare and maintain design history files, risk management documentation, verification and validation protocols, and reports.
Lead design reviews and ensure all deliverables meet technical, quality, and regulatory expectations.
Collaborate closely with Operations, Quality, and Regulatory Affairs to ensure a smooth transfer from development to manufacturing.
Participate in product testing, verification, validation, and clinical evaluation support activities.
Support continuous improvement initiatives to enhance design processes, manufacturability, and product performance.
Evaluate customer and user feedback to drive design improvements and address post-market needs.
Provide technical guidance and mentorship to junior engineers and technicians.
Manage project timelines, resources, and budgets to ensure on-time and on-scope execution.
Coordinate with suppliers and contract manufacturers to define component specifications, materials, and process requirements.
Ensure compliance with quality system requirements and participate in internal and external audits as needed.
Communicate effectively with cross-functional stakeholders to align on priorities, milestones, and technical deliverables