R&D Project Manager - Salt Lake City, Utah United States - 36576

JOB DESCRIPTION

WHY IS THIS A GREAT OPPORTUNITY?

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This group is pursuing new uses for a novel technology that will prove a game changer in its industry niche if successful.  Current product is in phase 1 clinical trials.  This is a new position, so the new person in this position can literally build the position!  The position can grow into some new directions too, including building a team.  This person will report to a very experienced medical device engineer who is not a micromanager.  They will also be surrounded by a top-notch team of engineers, scientists, and businesspeople.  

JOB DESCRIPTION

We’re looking for an experienced Project Manager to work in partnership with executive management and product development teams to support the company’s development programs, strategic plans, and to escalate risks when programs are off track. 

Responsible and accountable for planning and tracking product development activities associated with drug / medical device combination products.

This position interfaces with a cross-functional team, receiving input on priorities among different projects, and is responsible to manage timelines (particularly the critical paths), resource allocation and material management based on given priorities. Successful candidate needs strong experience in medical device and/or pharmaceutical development to understand and help ensure that company complies with appropriate regulatory and documentation requirements.

In addition to project management responsibilities, this person is also responsible for Design Assurance / Quality responsibilities associated with the development and manufacture of combination products. Aspects of this role involve ensuring compliant application of the many elements of Design Controls and Risk Management including: Design Inputs, Traceability Matrices, Verification and Validation activities, and risk analyses.

QUALIFICATIONS

• Must have 5+ years’ experience in and knowledge of project management and medical device and/or pharmaceutical development.  Must be experienced with project management tools such as Microsoft Project.
• Knowledge of drug/device combination products a plus.
• Confirmed organizer, communicator, detail-oriented and effective project manager.
• Engineering background with a minimum of a BS degree
• Exposure to, if not solid working knowledge of 21CFR820, ISO 13485, ISO14971 and other related regulations.
• Must possess and be able to demonstrate sound engineering fundamentals.
• Able to directly support and take direction from several functional heads.
• Passionate attention to detail and desire to “get it right.”
• Strong computer skills, MS Office, and MS Project
• Collaborative / customer service style communication skills, both oral and written.

Education:
University - Bachelor's Degree/3-4 Year Degree