Job Description
Engineering Project Manager (m/w)
Location: Schweinfurt, Bavaria
Your assignments
Transfers user requirements and system risk analysis into device-specific, technical requirements
Reviews the resulting Technical Specification with the Global Therapy Program
Estimates expenditures for resulting specification catalog and subsequently coordinates project contents regarding time and resources with the Global Therapy Program
Ensures regular coordination with the Global Therapy Program and provides initiative for further technical development
Identifies and monitors project risks and defines risk-reduction measures to ensure that project goals are met (time, product/project costs, quality)
Possesses know-how regarding machines and their technical interfaces
Clarifies requirements and their technical feasibility
Assesses if projects are feasible with available resources
Defines specification and product architecture and subsequent development of the technical design
Determines product structure and allocates work packages to operational units within the PEC and controls internal PEC resources for technical implementation (technical guidance/supervision)
Plans and monitors project and product costs as well as adherence to the time schedule
Plans and implements activities to ensure adherence to the development process
Project status reports and reporting
Device risk management during the development phase including the overall system
Cross-functional control of production transfer
Your profile
Degree in natural science or engineering (Graduate, Bachelor, Master)
Several years of professional experience, preferably in the field of Research & Development (R&D) and project management
Knowledge in fields of software, electrical engineering, measurement and control technology, mechanical engineering, dialysis therapies
Practical project management experience
Relevant experience of the requirements (21 CFR 820) and audits executed by the US federal agency FDA
Experience in transferring CE-marked medical devices into the US market (510k) including registrations (510k)
Expert knowledge of MS-Office programs
Knowledge of R&D-relevant applications (e.g. risk management, Requirement Management, etc.)
Excellent command of English both written and verbal
Ability to work independently and on his/her own responsibility and quick perceptive comprehension
Excellent communication/contact and conflict management skills, distinct assessment and decision-making skills as well as ability to delegate
Willingness to travel