Project Manager I/II, Technology Transfer - Salt Lake City, United States - bioMérieux SA

Description

Project Manager I/II, Technology Transfer - HYBRID

bioMérieux currently has Project Manager openings in the Technology Transfer department on the following team:
Instrument Development, Sustainment, and Reliability.

Project managers on this team work closely with our engineers, instrument manufacturing team, and program managers leading change control and implementation activities related to our FilmArray and SpotFire benchtop medical diagnostic equipment.

At bioMérieux, Technology Transfer Project Managers work with the most innovative and dedicated scientists and engineers in the medical device industry

Project Managers on all Technology Transfer teams facilitate the transfer, sustainment, and improvement of products and processes from research and development to a final product ready to send to customers.

They ensure changes are documented and maintained according to regulatory standards and quality system requirements.

They do this by collaborating cross-functionally to ensure that all changes are properly understood and documented appropriately within the guidelines of bioMérieux's quality management system (QMS).

Primary responsibilities include:
Lead and monitor multiple projects throughout the project lifecycle
Write, revise, and present change notifications, change orders, protocols and reports, work instruction documents, standard operating procedures, qualifications, product specifications, and verification and validation plans
Develop and maintain timelines, schedule meetings, create agendas and presentations, facilitate discussions, and document meeting minutes and action items
Adhere to bioMérieux's Change Control Process and Quality Management System to identify the associated impact, risk, and testing
Collaborate with other departments and stakeholders to ensure transfer projects and activities are scoped and completed on schedule

The ideal candidate must have:
Bachelor's degree in relevant scientific or engineering field.

Appropriate college level coursework and/or significant related experience may be considered in lieu of degree.
Relevant MBA and/or PMP certification from Project Management Institute a plus

Project Manager I Qualifications

3 or more years of relevant work experience including:

FDA 21CFR 820, ISO 900/13485 and/or cGMP/cGLP compliant environment

FDA or ISO regulated, non-IVD industry experience may be considered

Work in manufacturing, medical device, or regulated environments preferred
Project management or related experience

Project Manager II Qualifications

6 or more years of relevant work experience including:

FDA 21CFR 820, ISO 900/13485 and/or cGMP/cGLP compliant environment

FDA or ISO regulated, non-IVD industry experience may be considered

Work in manufacturing, medical device, or regulated environments preferred
Project management or related experience

Ability to work in a fast-paced and dynamic environment
Strong analytical and problem-solving skills
Excellent communication skills verbal, written, and presentation

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