Job Description

Project Manager, CPM, Manufacturing, vendor qual, FDA, Medical Project Manager, CPM, Manufacturing, vendor qualification, Scheduling, FDA, Medical devices, Lean Skills Required - Project Manager/PMP, Manufacturing, vendor qualification, Scheduling, FDA/ISO exp, Medical devices, Lean

Project Manager/Project Engineer
Direct Hire/Perm
Newberrytown, PA area (off the 83)

We are looking for an experienced PROJECT ENGINEER with a strong background in Project Management (ideally a Certified Project Manager) to take on a key role working with customers in the development of new products, equipment, and changes/improvements to existing products including conducting product testing as required.

A strong background in scheduling and working with outside vendors is a key to the success here, as you will be working with the assessment and selection of vendors, making sure they are on track, qualifying them in the early stages.

On the engineering side, you will be responsible for the development of manufacturing system concepts, including the development of operating procedures and quality assurance documents to be transferred to operations at the start of product manufacturing and subsequent training of manufacturing personnel. These responsibilities include maintaining compliance with FDA regulations and ISO standards as they apply to the performance of each development activity.

Essential Job Functions:
Assume overall responsibility for assigned projects.
Develop project plans for assigned projects including schedules, resource estimates, and risks.
Manage projects to successfully completion.
Develop manufacturing processes and process controls required for specific projects.
Assist with the design and selection of tooling and high volume automation equipment for specific projects.
Provide design for manufacturing input for product designers on specific projects.

Education/Experience Required:
Bachelor's Degree in Engineering with a minimum of 10 years experience in project engineering.
Project experience includes product development and engineering capital projects.
Certified Project Managers (PMP) will be given priority consideration.
Experience in medical device or pharmaceutical manufacturing requirements (ie FDA. GMP, ISO) is required.
Direct experience in the manufacture of class I and class II medical devices and ISO 13485 is preferred.
Must have strong written and oral communication skills.
Must be PC literate in Microsoft Office applications including Microsoft Project, Word and EXCEL and in ERP and EDMS systems like MasterControl.
Familiarity with Six Sigma, LEAN manufacturing or other vigorous quality control programs is desirable.
Experience in automated production of disposable, molded plastic medical devices, such as syringes, is highly desirable.