Address
Form of workJob Description
Lead Coordinator, Human Factors
Must be available to work hybrid in Plymouth, Minnesota
The Renal Human Factors team is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide Human Factors activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue ***s mission to save and sustain lives.
The Lead Human Factors Coordinator role is responsible for coordinating Human Factors studies from initiation through completion. Additionally, this role supports the HF team during the Human Factors/usability engineering process and develops study coordination procedures to improve effectiveness, speed and digitalization of study planning and HF team internal communication.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Leading/Supervising:
1) Lead the planning and organization of Human Factors study logistic-relevant work to keep a smooth study preparation and execution process, including (but not limited to) participant recruiting, ordering and shipping supplies/equipment, communication with third-party personnel, negotiating quotes with vendors providing study service, developing statement of work, processing non-disclosure agreements and payment, note-taking, data transcription & verification, etc.
2) Responsible for communication with Ethics &Compliance (E&C), Legal and Regulatory team members to advise HF Engineers on study timeline, project costs, *** established Fair Market Value rates, vendor contracts, *** local/global interaction policies/laws and regulations across different countries and regions. Develop and maintain job aids to guide HF Engineers on relevant legal/E&C processes
3) Design, deploy and maintain HF team site for information and process digitalization
4) Instruct HF Engineers and/or study coordinators on study planning & coordination process. Advise on ***s internal E&C policies and processes for holding HF studies with HCPs in the U.S. and OUS. Advise on required study contracts.
Supporting:
5) Perform study budget estimations and track and monitor project budgetary commitments
6) Actively reduce study risks through problem identification, contingency plans and escalation
7) Collaborate with HF Engineers to assess vendor capabilities, work with procurement to onboard new vendors, and update internal supplier list.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
1) Familiar with the standard Human Factors/usability engineering process
2) Ability to manage simultaneous HF study logistics to meet established timelines within approved budgets
3) Strong interpersonal and communication skills
4) Ability to act independently, make decisions and solve coordination work problems with minimal assistance
5) Fluent in general MS Office tools
6) Able to proactively improve processes, initiate projects and implement changes
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Bachelors degree in engineering or relevant field
1+ year experience in medical device industry preferred
Must be available to work hybrid in Plymouth, Minnesota
The Renal Human Factors team is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide Human Factors activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue ***s mission to save and sustain lives.
The Lead Human Factors Coordinator role is responsible for coordinating Human Factors studies from initiation through completion. Additionally, this role supports the HF team during the Human Factors/usability engineering process and develops study coordination procedures to improve effectiveness, speed and digitalization of study planning and HF team internal communication.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
Leading/Supervising:
1) Lead the planning and organization of Human Factors study logistic-relevant work to keep a smooth study preparation and execution process, including (but not limited to) participant recruiting, ordering and shipping supplies/equipment, communication with third-party personnel, negotiating quotes with vendors providing study service, developing statement of work, processing non-disclosure agreements and payment, note-taking, data transcription & verification, etc.
2) Responsible for communication with Ethics &Compliance (E&C), Legal and Regulatory team members to advise HF Engineers on study timeline, project costs, *** established Fair Market Value rates, vendor contracts, *** local/global interaction policies/laws and regulations across different countries and regions. Develop and maintain job aids to guide HF Engineers on relevant legal/E&C processes
3) Design, deploy and maintain HF team site for information and process digitalization
4) Instruct HF Engineers and/or study coordinators on study planning & coordination process. Advise on ***s internal E&C policies and processes for holding HF studies with HCPs in the U.S. and OUS. Advise on required study contracts.
Supporting:
5) Perform study budget estimations and track and monitor project budgetary commitments
6) Actively reduce study risks through problem identification, contingency plans and escalation
7) Collaborate with HF Engineers to assess vendor capabilities, work with procurement to onboard new vendors, and update internal supplier list.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
1) Familiar with the standard Human Factors/usability engineering process
2) Ability to manage simultaneous HF study logistics to meet established timelines within approved budgets
3) Strong interpersonal and communication skills
4) Ability to act independently, make decisions and solve coordination work problems with minimal assistance
5) Fluent in general MS Office tools
6) Able to proactively improve processes, initiate projects and implement changes
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Bachelors degree in engineering or relevant field
1+ year experience in medical device industry preferred
