This person will manage all aspects of relatively complex product/process development/manufacturing transfer projects to completion. They will be responsible for project approval, direction, coordination, implementation and closure, ensuring consistency with company strategy, commitments and goals. This person will drive the cost, commitment and schedule of a project and focus all project support to meet project goals. They will collaborate with management and customer to establish objectives, deliverables, timeline expectations and project team(s). They will also ensure all GMP, ISO and other stakeholder requirements are satisfied for a project. This person will influence and coordinate projects across functional boundaries such as the customer, engineering, quality, regulatory, operations and finance. This position will require a high level of leadership and organizational skills with minimal supervision. This person will need strong customer service and communication skills for both internal and external customers. They will need the ability to interact with customers in a meaningful and constructive manner to facilitate agreement on deliverables, timing and cost expectations throughout the project. They will develop full scale project plans including detailed work breakdown structures (Gant Chart), and facilitate the definition of project scope, goals and deliverables. They will ensure that projects stay within budgeting objectives and they must understand and be capable of managing billable hours, capital expenses and overall project costs. They will be required to provide project evaluations and assessments of results in the form of reports. This person will need to have strong team leadership capabilities such as negotiation skills, mentorships skills, written and verbal vocabulary and presentation skills, ability to manage conflict, ability to influence team members and associates to deliver on project commitments and promises, ability to form constructive working relationships with a variety of personalities. This person must have a broad knowledge of manufacturing processes common to medical device manufacturing: injection molding, metal cannula processing, metal fabrication techniques, terminal sterilization (EO/Gamma), and packaging, and a broad knowledge of medical device design controls and ISO Quality System practices.
Education and/or Experience
BS or associates degree in a technical discipline. Five years experience in a medical device process development and/or manufacturing environment. Two years experience managing teams in a project manager role.