The Opportunity:

Responsible for implementing and maintaining the effectiveness of the quality system. Executes to defined business results expected from a project. Is responsible and accountable for achieving those results, where results are expressed in terms of compliance with Design Control and/or Change Control policies, quality, time, scope and cost.

What you’ll do:

• Lead the team through the translation of management and customer needs into project goals.
• Develop a preliminary implementation plan and propose contingency plans to respond to unforeseen events.
• Maintain compliance with regulatory agencies, quality system and project goals to assure that Design Control and compliance requirements are met.
• Manages team charter including project goals along with the decision-making process.
• May function as the project contact with third party vendors.
• Ability to interface with other disciplines, customers, internal clients, project staff and internal and external experts as required.
• Prepare and present written and oral reports and other presentations to internal and external audiences.
• Interprets Results/Recommends Options: Determine if results match requirements. Ensures that the necessary documentation is in place to meet quality and regulatory requirements.
• Integrates Project Activities: Develops detailed, cross functional, realistic timelines including resource requirements, plans for contingencies, estimates buffers, etc. Converts goals to tasks, gathers information regarding effort, resources, and technical complexity and translates that information into project specifications. Implements project plans to meet project goals, considers technical, resource, and regulatory requirements.
• Recommends innovative ways to improve performance, quality and enhance profitability on an ongoing basis, modifies work processes and procedures in line with current quality and regulatory requirements. Works with cross-functional team to resolve resource conflicts, allocations.
• Evaluates the impact of project changes and adjusts implementation activities to meet revised. Clearly communicates any changes and the impact to original plan to the cross-functional team and senior management in a timely fashion.

Qualifications:

• Bachelor’s degree in biomedical engineering or equivalent
• Must have at least 1 – 2 years of experience in project management.