R&D Project Coordinator - Fremont, CA, US

JOB SUMMARY · The R&D Project Coordinator – Intern/Co-op is responsible for working under the supervision of technical project managers and R&D engineers in coordinating the execution of defined R&D project support tasks within a regulated medical device product environment.   Pr ...

Job description

JOB SUMMARY

The R&D Project Coordinator – Intern/Co-op is responsible for working under the supervision of technical project managers and R&D engineers in coordinating the execution of defined R&D project support tasks within a regulated medical device product environment.   Project coordination involves supporting the tracking of project documentation deliverables, following up on the status of project tasks and action items assigned to project team members and basic problem solving.  Engineering coordination involves supporting engineering activities, studies and evaluations for design, development and testing. This position is based in Fremont, CA Office. 

DUTIES & RESPONSIBILITIES

• Supervised preparation, maintenance and updating of status of items in the project master deliverables list.
• Supervised tasks for supporting engineering activities, studies and evaluations.
• Assist R&D project managers and engineers to follow up on remaining deliverables within the document management system.
• Assist R&D project managers to obtain the status of project tasks and action items assigned to project team members.
• Assist R&D project managers and engineers with preparing project documentation for project phase reviews and the 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.
• Assignments may rotate between R&D departments.

Learning Opportunities

• Hands-on work collaborating with R&D project managers, engineers, technical leads and cross-functional team members.
• Training and hands-on exposure to product documentation management in a highly regulated medical device environment.
• Hands-on exposure to projects involving engineering technology, tools and infrastructure for orthopedic robotic devices and accessories.
• Exposure to medical device project management processes and cross-functional teams.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required:

• 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.
• Familiar with the use of Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint).
• Basic problem solving and analytical skills.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• Knowledge of regulated industries – e.g. medical device, biotechnology, pharmaceutical.
• Prior experience or exposure in a regulated industry environment.
• General understanding and application of statistics and probability theory.

COMPETENCIES 

• Nimble learning
• Manage time and priorities well
• Utilize collaboration tools effectively
• Eager to invest in self-development
• Network and build 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 of time. 
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs. 
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• 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%).

 

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. ("THINK") is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee's eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.