ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Plan, manage, and control a technical project to transform an existing portfolio of bipolar forceps and other neurosurgical instruments into products ready for the EU market
• Review DHFs, create gap analyses, identify dependencies, and create a plan to fill the gaps and execute the plan
• Manage and execute the creation of an MDR-compliant DHF
• Integrate external development partners into the projects, and coordinate alignment between internal team members and external contributors
• Identify and manage project risks
• Monitor progress of the project, identify and escalate deviations from the project plan, and report regularly to management stakeholders
• Support CA specialists preparing for clinical projects as a consultant on project management tasks
• Order and manage external testing at certified test houses for electrical safety and biocompatibility
• Ensure the compliance of the internal design controls procedure and EU MDR
• Work cross-functionally, collaborating with engineers, QA/RA specialists, product management, and external contributors for project execution
• Communicate detailed project updates to management stakeholders within cross-functional meetings
• Other duties may be assigned

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• Bachelor's degree (B. A.) from a college or university in engineering or technical field of study
• 3-5 years related experience and/or training, or equivalent combination of education and experience
• Knowledge of engineering DHFs (design history files) and DMRs (device master records)
• Knowledge of European Medical Device Regulation (MDR)
• Experience leading a team of internal and external contributors for project execution
• Experience with project management tools and Office programs
• Experience providing detailed progress updates to management stakeholders

Your ZEISS Recruiting Team:

Clara Cresswell