Project Manager

Project Manager

IMDS is a leading innovator in contract full-service medical device development and manufacturing providing innovative solutions from product concept to real life especially within the orthopedic industry. We are the only company of our kind that can provide our partners all the steps of the product realization process with service areas focused on product development preclinical testing and contract manufacturing which we call Co-Innovation Discovery Research and Product Sourcing. We currently have an opening for a Project Manager. Position Summary Under the direction of the Senior Project Manager the Project Manager performs tasks associated with medical device product development including but not limited to project planning design analysis testing supply chain management and documentation. In addition the Project Manager will be expected to communicate with Partners as necessary to effectively accomplish project tasks. The Project Manager works to improve current processes and lead the DFM and improvement initiatives for new products. Key Roles and Responsibilities Other duties may be assigned Communication Performs the duties as primary point of contact for all customer related items. Familiarizes the PSV team with the customer needs specifications design targets the development process design standards techniques and tools to support task performance. Conducts status meetings and provides regular milestone updates to Executive Management. Provide daily weekly status reports in a variety of formats (both written verbal) to varying audiences Ensures deliverables are prepared to satisfy the project requirements cost and schedule and executes plan to completion of these deliverables. Coordinate team logistics Assures that the team addresses all relevant issues within the specifications various standards. Initiates sub-groups or sub-teams as appropriate to resolve issues and perform tasks in parallel. Responsible for facilitating all regulatory requirements are met on all projects. Works with Functional Managers and the team to obtain necessary resources to support the team s requirements. Coordinates project personnel activities to ensure project progresses on schedule and within prescribed budget while maintaining quality standards. Coordinates the review presentation and release of project documentation. Responsible for providing performance feedback for each participant on the project to appropriate Functional Manager. Technical Develops edits maintains and publishes program management documentation including scope definitions schedules risk management reports and resource estimates for various initiatives. Work closely with Plant Production Quality and Engineering personnel to ensure that production schedules and Pre-Production processes are completed in accordance with customer expectation Develops project plans and formulates all aspects of new product development and other projects including defining the project goals and objectives activities milestones costs of project equipment and other resource requirements. Maintains the Design History File (DHF) as applicable for active product development projects and supports the Design Control efforts for these products. Participates and sometimes leads improvement activities across facility and assists and directs other Project Managers on their improvement activities. Coordinates analyzes and determines solutions to supply chain management. Includes pre-planning for supply chain requirements and organizing necessary vendors prior to production needs. Working with engineering and other departments to produce cost estimates for new designs. Identifying ways to reduce production costs of legacy and new products. Leadership Coordinate all customer engineering deliverables including customer drawings prototype samples and production samples. Manage customer project review meetings and internal project review Utilizes influence to lead a cross functional team comprised of but not limited to the following sales customer service IT engineering marketing manufacturing and operations to ensure completion of the project. Provide leadership to cross-functional team members while driving to a common goal. Required Knowledge Skills and Abilities Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company s policies and practices. Works within the scope of QSR (Quality System Regulation) and ISO (International Standards Organization) requirements for medical products. Bachelor s degree in Mechanical Manufacturing or other related Engineering disciplines. More than two years experience as a Project Manager or equivalent combination of education and experience. Working knowledge of Quality analytics tools including but not limited to SPC FMEA PFMEA preferred. Strong working knowledge of Microsoft Office applications including Word Excel PowerPoint and Project. Fluent in corporate MRP principles. Ability to read and interpret complex blueprints. Excellent knowledge of GD& T. PMP certification is desirable. Language Skills Excellent communication skills Ability to read analyze and interpret common scientific and technical journals financial reports and legal documents. Ability to respond to common inquiries or complaints from customers regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management public groups and or boards of directors. Reasoning Ability Ability to define problems collect data establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential 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 is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand walk use hands to finger handle or feel reach with hands and arms and stoop kneel crouch or crawl. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus. To apply go to www.imds.net select careers then current openings