Project Manager (Med Device)

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.

Duties and 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

Qualifications

• 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.

Education

• BS or MS in Engineering is required

• PMP or other certificated preferred

Experience

• 3+ years experience in engineering for medical devices

• Experience with concept to commercialization is preferred

Skills, Knowledge, and Abilities

• Strong analytical and problem-solving skills

• Excellent verbal and written communication skills are essential

• Excellent computer skills needed include Microsoft Office or equivalent applications

Physical Demands of Position

The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee sits, stands, uses hands, arms, and fingers to perform routine tasks such as computer use, telephoning, faxing, copying, filing, etc. Normal vision and hearing are needed, and the ability to communicate effectively to others on telephone, in person, or via written communication. This position will work primarily in a laboratory environment, but also required to work in manufacturing environments, where variable conditions may exist. This is not an exhaustive list of responsibilities, skills, duties, requirements, or working conditions associated with this job. While this list is intended to be an accurate reflection of the position, the company reserves the right to revise the functions and duties of the job or to increase or decrease the scope of responsibilities when circumstances dictate, as determined by management.