R&D Project Manager

Aptyx•Charlotte, NC

About The Position

Project Manager (PM) is responsible for planning, overseeing, and leading projects from ideation through completion. This role requires interaction with a range of internal and external stakeholders, most often managing several moving project parts simultaneously. The PM role is responsible to plan and designate project resources, prepare budgets, monitor progress, and keep stakeholders informed the entire way. The PM works to ensure that all team members have the required information and resources to carry out their tasks effectively. The PM is responsible for conducting projects in compliance with Aptyx's core values, and in compliance with applicable regulatory requirements. The primary goal of the PM is to finish projects on time and on budget and to communicate to Business Development changes to scope, budget, or timing that may affect customer expectations. This role of this position impacts Quality objectives by ensuring timeliness of projects and ensuring customer satisfaction.

Requirements

Technical skills must include disposable design and development background, materials knowledge, and prototyping
3 years of project management or project engineering experience is highly preferred to plan and conduct complex development projects within FDA and ISO regulatory requirements.
BS or MS in Engineering is required
3+ years experience in engineering for medical devices
Experience with concept to commercialization is preferred
Strong analytical and problem-solving skills
Excellent verbal and written communication skills are essential
Excellent computer skills needed include Microsoft Office or equivalent applications

Nice To Haves

PMP or other certificated preferred

Responsibilities

Responsible to follow all applicable Aptyx SOP's included in the Training Matrix.
Manage projects for disposable medical devices from concept to production.
Communicate to the customer any issues and the status of the project.
Prepare and support product development and quality planning (project schedule, resources, budgets, Design and Development Plan, etc.)
Participate in the quotation process for projects.
Plan the project management approach for each project with the best interests of the customer and the success of Aptyx in mind.
Coordinate timing and resources between departments for personnel and equipment
Identify resource needs for each project and communicate plans for Senior Management
Provide customers with up-to-date schedule information and communicate changes immediately
Collaborate with outside vendors on the sourcing of catheter materials, components, and processing.
Drive the completion of project deliverables, monitor scope, and timelines, and communicate to Business Development to ensure project work content is properly quoted and executed.
Contribute to technical and design efforts when time allows and where expertise and skills improve project success.
Identify opportunities for improvement of the project management team and communicate needs to Senior Management