Job Description The Senior Project Engineer, R&D Instrument Tray Team performs tray instrument development work. Actively participates on, and sometimes leads, multifunctional teams to advance assigned projects through the development process and commercialization.
Under supervision, performs work that is varied and that may be somewhat difficult in character. Some evaluation or originality is required.
Responsabilities Direct and manage the workflow within the scope of assigned projects. Manage projects and tasks, address design issues, maintain products or continuously improve product.
Utilize / Manage design controls within the New Product Development design controls process. Adhere to project plans and timelines within the scope of the Design Control guidelines.
Develop verification and validation protocols and technical reports. Defining strategic plans to cover Verification & Validation activities Establish Interface Analysis, DIOVV and RMF Utilize and manage the Design Change Process by Coordinating R&D activities pertaining to change requests Gathering information pertinent to the assigned product change Undertaking Technical Reports & Assessments Collaborating with BML on test plans definition Defining strategic plans to cover Verification & Validation activities Updating Interface Analysis, DIOVV and RMF as result of change requests Actively participate in cross functional teams Addressing Non-Conformities / Corrective- / Preventive Actions of existing medical devices Supporting Manufacturing Transfers Developing line extensions Coordinate Merger&Aquisition Integration und Remediation activities.
Act as expert in one or more areas of competency or subject matter expert Establish and maintain relationships with the key groups to recognize and anticipate trends and user needs.
Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs. ECR / ECN owner CAPA owner Representative of quality documents in the R & D Instruments Tray Team Divisional contact and R & D representative for the Post Market Surveillance process Conception and design of system supplements and line extensions Technical contact person for customers and suppliers (global) Continuous improvement of the tray development procedure according to internal and external guidelines Qualification and Experience Bachelor's degree in Engineering or related, Masters degree preferred Minimum of 2 years of related experience in the medical device, pharma industry or equivalent.
Demonstrated ability to lead complex initiatives from concept through release. Demonstrated ability to make complex decisions.