SUMMARY: The primary role is to lead moderate to high complexity projects (~ 10 core team members, project cost $0.5M to $5M, multi-site) in support of critical business objectives.
The role will support both New Product Development and Major Sustaining projects.
The Senior Project Manager is responsible for leading the cross functional team in planning, daily management and execution, on time delivery, implementation, and commercialization.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Establish clear project objectives and deliverables.
- Facilitate the building of complex project plans
- Utilize master schedule and daily management to drive tasks to completion.
- Use key project metrics to maintain the health of the project.
- Establish project budget estimation and manage project to budget.
- Use the issue tracker to implement effective countermeasures and drive countermeasures to closure with a sense of urgency.
- Establish a risk register to anticipate highest project risks and drives team to head off risks and manage contingency plans.
- Mentor team members and proactively work with functional managers to address issues.
- Lead a cross functional, multi-site, matrixed team to delivery on commitments.
- Regularly communicate with core team members, functional managers, and leadership team to ensure alignment.
- Effectively communicate difficult information to the leadership team.
- Manage the project through our tollgate process
- DHF creation and support of audits of our Design Control process and documentation.
- Experienced with preparation and filing of regulatory submissions, 510k, Technical Files
- Develop an understanding of Danaher Business System (DBS) processes and tools and utilize in the execution of projects (i.e. Problem Solving Process (PSP) and Visual Project Management (VPM)).
CRITICAL SUCCESS FACTORS:
- Experienced in the development of medical devices.
- Has knowledge of all aspects of product development and brings expertise to help team members identify critical interdependencies and gaps.
- Strong interpersonal skills that create followership and motivate team members.
- Driven and motivated individual with demonstrated critical thinking and analytical skills.
- Unquestionably high ethical standards and attention to reputational and compliance risks.
- Organized thinker that can prioritize tasks in real time and exercise judgment in high-paced environment.
- Excellent oral and written communication skills to support design change documentation, team leadership, project updates, interaction with all levels within the organization and communication with external thought leaders.
- Sound computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook and Microsoft Project). Able to type 40 WPM.
- Bachelor's degree in Engineering or related technical field
- A minimum of 10 years' experience managing projects in medical device and/or other regulated industries using traditional waterfall and/or Agile methods
- A combination of education/training and 15+ years of the required experience listed above may be considered in lieu of a degree
- FDA Quality System Regulation Part 820 and ISO 13485 experience
- Preference will be given to candidates who are PMP certified
- Experience in deploying PMO processes, tools and templates
- Master's degree