Fractional Operations Project Coordinator-Human Factors/Medical Device

Job Description

Job Description

About the Role

We are a specialized Human Factors (HF) usability research team. We have a fully trained HF engineering staff, and are seeking a highly organized, logistics-driven Operations Project Coordinator to manage administrative and operational aspects of our upcoming medical device usability studies.

The ideal candidate does not need to perform engineering tasks but must possess a strong operational or project management background—ideally within life sciences, clinical trials, or medical devices—so they understand the vocabulary, deadlines, and compliance context.

Key Responsibilities

• Internal Timeline & Deliverable Management: Proactively manage the internal schedule for HF engineering deliverables (e.g., protocol drafts, report templates, data analysis).

• Buffer & QA Enforcement: Calculate and enforce realistic lead times for senior review and QA processes, ensuring technical experts submit drafts with enough lead time for reviewers.

• Accountability Partnering: Run brief status syncs with the HF team to track progress against upcoming deadlines and flag bottleneck risks to leadership before a due date is missed.

• Recruitment Vendor Management: Serve as the primary point of contact for external recruiting agencies; track screening metrics, manage schedules, and troubleshoot participant drop-outs/scheduling.

• Site & Lab Logistics: Coordinate scheduling, access, and setup requirements for our on-site usability lab as well as external market research facilities and clinical simulation centers.

• Supply Chain & Shipping: Manage the logistics of shipping time-sensitive study materials, prototype devices, and documentation to various testing sites.

• Administrative Project Support: Maintain study timelines, track vendor deliverables, and ensure all non-technical operational tasks are completed ahead of study launch dates.

Qualifications

• Proven experience as a Project Coordinator, Clinical Trial Assistant (CTA), or Operations Manager.

• Prior experience in a medical device, biotech, or clinical research environment is highly preferred (familiarity with terms like IEC 62366, FDA guidance, or IRB protocols is a major plus).

• Exceptional vendor management and communication skills.

• Strong proficiency with project management tools (e.g., Asana, ClickUp, Monday.com, or Excel) and MS Office 365

• Comfortable with a fractional, variable workload

BlackHagen Design was founded over 30 years ago in Orlando; our present-day offices are located in beautiful downtown Dunedin on the Gulf of Mexico. Our research and development business services multi-national Fortune 500 corporations and start-up ventures alike. We provide cutting edge research, innovation and product development resources in the medical, commercial and consumer markets, using state-of-the art methods and technologies. Our culture is a balance of business with the Florida lifestyle, professionalism with a casual charm and an international tempo.

Company Description

BlackHagen Design was founded over 30 years ago in Orlando; our present-day offices are located in beautiful downtown Dunedin on the Gulf of Mexico. Our research and development business services multi-national Fortune 500 corporations and start-up ventures alike. We provide cutting edge research, innovation and product development resources in the medical, commercial and consumer markets, using state-of-the art methods and technologies. Our culture is a balance of business with the Florida lifestyle, professionalism with a casual charm and an international tempo.