R&D Engineer Project Manager II

This is an onsite position. Local Candidates only.

Years

Experience:

3-6 yrs. +

Manager is looking for an Engineer who has worked in medical device with an R&D background who can support Projects. Will be responsible for initiating the project to out the door. Will operate in a quality system within R&D. Will be responsible for working with cross functional teams (R&D, Quality, Regulatory) to ensure that timelines are determined and kept, budgets are approved, creating the deliverables, initiating, and running team meetings and maintaining notes.

• Responsible for implementing and maintaining the effectiveness of the quality system
  
  Education:
• Bachelor’s degree required, strongly prefer in Engineering but will consider other disciplines like Biomedical, Science or Technical
• IDEAL IS Minimum of 3 years of experience in medical device but will consider other types of “Regulatory” background like Pharma, Diagnostics, or healthcare.
• Must have Microsoft Office knowledge with PowerPoint, Outlook, Excel, and Word.
• MS Project experience is Strongly preferred and Ideal but not required.
• Must have great communications, be organized and a self-started
• Does not need Project Management experience ONLY if the candidate has solid exp. medical device in Product development or Regulatory working with hardware and software development
• Will be managing change orders

• Medical device
• Project Management exp.
• R&D exp.

• Organized
• Great communication
• Self-starter, go getter

• 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.
• A project is a set of interrelated tasks that culminates in clearly defined business results.
• Bachelor's degree required preferably in Engineering.
• Exp. in medical device quality and design controls Organized Exp. in Microsoft Office tools
• Being able to understand what engineers are saying to put in project time line, schedule and run project meetings, be able to document results
• For new product development projects; the business results will typically include the launch of one or more products.
• Differences across the levels of Project Manager are dependent upon increasing project complexity and increasing level of expected independence.
• Each higher level incorporates the expectations from the lower levels.
• Manage moderately complex project or several smaller low complexity projects with the assistance from their manager.

• Provides risk assessments (both safety and project related) and communicates critical issues impacting product quality to management (Q01 and Q04.01.004)).
• Establish and maintain risk analysis as part of overall responsibility to control / reduce risk (QO4.01.001) Recognizes strategy; quantifies and evaluates risks; recommends actions and develops contingencies to cope with various scenarios.
• Able to analyze risk / reward trade-offs and make recommendations of appropriate path forward.
• Translates Project Goals:
• Translates project ADD goals into the day-to-day activities necessary to accomplish them.