Project Manager, Operations Management, Regulatory Compliance Specialist

Salary Range: $87,768.54 To $ Annually

Team:
Operations Engineering

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

The Project Manager leads teams developing manufacturing processes for complex medical device components. Works with customer and team to define and execute project plans associated with sustaining engineering, development, and transition to manufacturing. This position operates independently and under occasional guidance from management. The position provides experience and expertise to, a team of manufacturing engineers. The Project Manager ensures Pro Med’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Position duties and responsibilities include, but are not limited to the following:

Lead projects (75%)

• Simultaneously lead multiple complex projects, ranging from early feasibilities to commercial transfer
• Develop and implement project plan, including cost, schedule, risk and performance
• Monitor progress against project objectives and timeline
• Take ownership of risk management activities within projects
• Foster a sense of urgency within teams to address challenges quickly and efficiently
• Lead problem solving activities within project teams
• Analyze and synthesize data to make key process and project decisions
• Facilitate continuous improvement through debriefs and lessons learned activities

Document and communicate (25%)

• Collaborate with R&D, Operations, and Quality to complete key documentation tasks
• Maintain thorough meeting notes both with internal and external stake holders
• Author and/or review reports and presentations for internal teams and clients
• Communicate effectively with a wide variety of partners and audiences
• Provide timely communication on project progress updates to all relevant cross-functions and levels within the organization, including presentations to senior leadership

This job also requires performing other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• B.S. (+3 years of experience) in an engineering or physical science field
• Five years of experience in a regulated environment in lieu of education requirements
• Three years of experience with formal project management

• Experience leading teams in regulated environment
• Experience managing external customer relationships
• Strong interpersonal, written, and verbal communication skills
• Strong problem solving and critical thinking skills
• Knowledge of medical device, risk management, and cGMP regulations
• Familiarity with polymer or pharmaceutical processing equipment and phenomena

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.

• Exposure to heated/air conditioned, ventilated facilities with fluorescent lighting;
• Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position…