The Staff Engineer, R&D Instrument + Tray Team mentors and leads in segments of complex multifunctional teams to advance assigned projects along the design/development process, maintaining products throughout the entire lifecycle. Acts as an ex-pert in one or more areas of competency, may also act as subject matter expert. Performs implant and instrument design work as well as be instrumental in ad-dressing design issues and continuously improve products. Under general supervision, plans, conducts and supervises assignments. Re-views progress and evaluate results. Operates with appreciable latitude for unreviewed action or decision. Reviews progress with management. May direct work of Project Engineer or Sr. Project Engineer.
Particular tasks in general:
Direct and manage the workflow of Engineers and Sr. Engineers within the scope of assigned projects.
Manage projects and tasks, address design issues, maintain products or continuously improve product.
Adhere to project plans and timelines within the scope of the Design^ Control guidelines.
Act as expert in one or more areas of competency or subject matter expert
Lead and participate in complex cross-functional teams.
Establish and maintain relationships with the key groups to recognize and anticipate trends and user needs.
Mentor Professionals in best practices, industry trends and skill development.
Act as Independent Reviewer.
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, and often lead, 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.
Mentor engineers across locations in project management best practices and industry.
Manage and coordinate external consultants as needed.
Some budget responsibility
Representative in audits
Special particular tasks:
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
Bachelor's degree in Engineering or related, Master’s degree preferred
Minimum of 4-6 years of related experience in the medical device, pharma industry or equivalent. - Experience in leading complex initiatives from concept through release
Personal attributes: Demonstrated ability to influence a broad cross functional audience. Demonstrated ability to lead complex initiatives from concept through release. Demonstrated ability to make complex decisions.
Work From Home: Regularly scheduled daysTravel Percentage: 10%