Plan and manage/coordinate activities related to ophthalmic medical device product development projects throughout Surgical R&D using the global PDP (Product Development Process), allied systems and tools.
• Champion and lead projects as a project manager for ophthalmic medical device products, such as IOLs, Injectors and Viscoelastics (OVD).
• Assure design control compliance to all current quality system requirements.
• Identify and negotiate functional resources to assemble an appropriate cross-functional project team.
• Coordinate with Commercial and key project team members to interact with end users to gather VOC toward product design and development.
• Along with project team, lead the development and implementation of a project plan, schedule, budget and capital plan as required. Prepare and amended budget forecasts as required.
• Communicate effectively with R&D management, Commercial, Quality and Regulatory and other necessary functions regarding the status of all activities and align them to project deliverables.
• Inform management in a timely manner of any problems which may result in a delay in project schedules so that appropriate action may be taken. Identify means to minimize impact to the project.
• Plan, coordinate, & conduct formal and informal project design reviews for compliance. Document design input, output and verification.
• Provide Project direction to lead, make sound team based decisions, foster team work and maintain project goal oriented focus, drive team to meet established timelines. Determine and drive for stretch goals.
• Manage cross functional team, conduct team meetings and document. Generate project progress reports and update management during scheduled project meetings.
• Document project in accordance with internal and global quality standards and establish master record files associate with development and validation activities that support global product registrations.
Advanced degree in engineering discipline, preferably Mechanical, Biomedical or Chemical Engineering. PMP certification a plus, but not required.
Minimum of 5 years of relevant experience in the industry, including 2 years of project management experience or demonstrated ability to lead and influence others without direct authority. Minimum of 5 years in New Product Development.
Excellent verbal, written and electronic communications skills. Demonstrated leadership skills. Ability to communicate and interact at all levels from senior management to staff level. Ability to translate customer requirements into measurable design goals/input. Competency in Microsoft Project, Microsoft Word, Microsoft PowerPoint, Excel & SharePoint.