R&D Project Coordinator

1 month ago


Fremont, California, United States THINK Surgical, Inc. Full time
Job Overview

The R&D Project Coordinator role at THINK Surgical, Inc. involves supporting the execution of defined R&D project support tasks within a regulated medical device product environment. This position requires collaboration with R&D project managers, engineers, and cross-functional team members to ensure project deliverables are met.

Key Responsibilities
  • Coordinate project documentation deliverables and track project status.
  • Support engineering activities, studies, and evaluations for design, development, and testing.
  • Assist R&D project managers in obtaining project task and action item status from team members.
  • Prepare project documentation for project phase reviews and design history files.
  • Work under the supervision of an R&D technical project or engineering lead to assist with defined aspects of medical device or device infrastructure/tools/processes projects and initiatives.
Learning Opportunities
  • Collaborate with R&D project managers, engineers, and cross-functional team members to gain hands-on experience.
  • Training and hands-on exposure to product documentation management in a highly regulated medical device environment.
  • Exposure to medical device project management processes and cross-functional teams.
Requirements
  • Minimum two years of undergraduate study or graduate student pursuing a technical or business course of study, or recently graduated with a degree/certificate in engineering, science, mechanical engineering, computer science, biomedical engineering, business, or related field.
  • Familiarity with Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint).
  • Basic problem-solving and analytical skills.
  • Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Preferred Qualifications
  • Knowledge of regulated industries, such as medical device, biotechnology, or pharmaceutical.
  • Prior experience or exposure in a regulated industry environment.
  • General understanding and application of statistics and probability theory.
Competencies
  • Nimble learning
  • Effective time and priority management
  • Utilization of collaboration tools
  • Eagerness to invest in self-development
  • Networking and building relationships
  • Effective communication and interpersonal skills
  • Ability to present to a group on own work and contributions to assigned projects
Physical Demands & Work Environment
  • Must be able to remain in a stationary position and operate office equipment for a prolonged period.
  • Physical activities include constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Occasionally work around moving mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays, and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to 5%).

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