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Form of workStefanini Group is hiring!
Stefanini is looking for Lead Human Factors Coordinator in Plymouth, MN (Hybrid) Location
For quick Apply, please reach out to Shubham Singh - call: 248-728-2629 / email: Shubham.Singh@stefanini.com
Work Hours: M-F (40 hours)
Work Location: Plymouth, MN (Hybrid)
Shift: 1st Shift
Job Description:
- 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 client'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.
Leading/Supervising:
- 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.
- 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, client 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.
- Design, deploy and maintain HF team site for information and process digitalization.
- Instruct HF Engineers and/or study coordinators on study planning & coordination process. Advise on client'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:
- Perform study budget estimations and track and monitor project budgetary commitments.
- Actively reduce study risks through problem identification, contingency plans and escalation.
- Collaborate with HF Engineers to assess vendor capabilities, work with procurement to onboard new vendors, and update internal supplier list.
Job requirements:
- Bachelor's degree in engineering or relevant field.
- 1+ year experience in medical device industry preferred.
- Familiar with the standard Human Factors/usability engineering process
- Ability to manage simultaneous HF study logistics to meet established timelines within approved budgets. Strong interpersonal and communication skills.
- Ability to act independently, make decisions and solve coordination work problems with minimal assistance.
- Fluent in general MS Office tools.
- Able to proactively improve processes, initiate projects and implement changes.
***Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives***
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Education: Bachelor (BA, BS...)Employment Type: CONTRACTOR
