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Project Manager
Ref No.: 18-13077
Location: raynham, Massachusetts
Position Type:Direct Placement
Start Date: 10/04/2018

Strong focus on leading and driving collaborative cross-functional teams globally. Will lead the project team for the transition of new products from engineering into production.
Essential Job Duties and Responsibilities:
· Serve as project manager of a multifunctional team to drive new product development activities from concept to launch.
· Develop and confirm methods for reprocessing of assigned devices
· Write verification and validation documentation and conduct required testing as needed
· Familiar with aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
· Assist regulatory compliance efforts and verification and documentation related company standards
· Author, revise, train, and provide support for production work instructions when needed
· Identify new processing needs and perform continuous improvement to support sustaining efforts
· Proficient in the investigation and management of CAPA's, root cause analysis, complaints, and escalations.
· Lead and facilitate process improvement activities
· Other responsibilities may be assigned & not all responsibilities listed may be assigned
Education, Skills, & Experience Needed to Perform Position Function:
· Bachelor degree in Chemical, Mechanical, Electrical Engineering, Biomedical Engineering, or equivalent.
· Bachelor's degree required
· 2-5 years of experience with project management , including expertise executing multiple projects simultaneously
· Prior experience in the medical device industry is preferred
· Prior experience in manufacturing set ups in MRP systems required
· Experience in SAP or JDE required
· PMP certification Preferred
· Experience working with and effectively leading cross functional teams essential
· Proven skills with project management methodologies (developing project charters, defining and managing scope, building timelines, communicating plans, and managing cost and risks)
· MS Project expertise, as well as strong Word, Excel and PowerPoint skills required
· Proven ability to deliver high-quality projects on tight schedules
· Strong and effective decision making skills a must
· Ability to influence and build relationships and demonstrate leadership in all interactions
· Strong verbal, written and interpersonal skills, positive attitude, an ability to engage and create trust in others to build and foster team relationships
· Strong ability to coach and mentor resources
· General understanding in the areas of mechanical product design and product assemblies a plus
· Manufacturing industry experience a plus