link to Video of Tack Endovascular System

This animation is provided for general information only. It is not intended to provide clinical instructions for use (IFU). Always read and understand the IFU supplied with the device prior to use.

CAREERS

Clinical Site Manager (CSM)

The CSM supports multiple activities for the conduct of clinical research studies, operations and special projects in compliance with applicable regulatory standards, IRB/EC policies and procedures and Intact Vascular internal requirements.  This position works with minimal supervision and directly with study management and the study team.

Principle Responsibilities

  • Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. 
  • May assist in preparation of sections of the Investigational Plan, study materials and/or training.
  • Will interface with, and ensure training of investigators, site staff, and assigned Intact Vascular staff. 
  • Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review) and site closeout activities.
  • Responsible for coordinating field activities with clinical site needs to ensure enrollment and study execution.
  • Assist in follow-up and resolution of site issues. 
  • Assist in review of adverse event information. 
  • Assist in device allocation, reconciliation and compliance, review, and conclusion of device complaints.
  • Assist in preparation of annual, interim and final reports and presentations.
  • May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs).
  • Able to refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks.
  • Contribute to ongoing SOP development and review.
  • Participate in training to enhance knowledge base.

Secondary Responsibilities

The successful candidate must have / be:

  • Strong verbal and written communication skills, technical and problem solving skills
  • Able to read, analyze and interpret general business documents, technical procedures, and standard operating procedures
  • Able to work effectively, independently and on cross-functional teams
  • Able to write reports, business correspondence and procedure manuals effectively
  • Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
  • Develop solutions to a variety of problems of moderate scope and complexity
  • Able to refer to policies and regulations for guidance

The above statements are intended to describe the general level of work being performed by people assigned to this job.  They are not intended to be an exhaustive list of all responsibilities.

Job Requirements

  • Education Level: Bachelor’s Degree and 1+ year of experience in clinical / clinical research setting.
  • Knowledge of ICH and GCP Guidelines
    Strong computer literacy with Microsoft Office

Additional Skills

  • Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
  • Understanding of Clinical Operations
  • Experience working with small cross-function product/process development teams.
  • Able to generate and communicate project strategies and scenario plans to team members, management, board members, etc.
  • Ability to work independently

Special Requirements

  • Environmental Situation
    • General Office Environment
    • Medical Device Research Manufacturing Environment
    • International and Domestic Travel
  • Physical Functionality
    • Varying work schedule
    • Prolonged periods of standing, sitting and walking
    • Up to 80% overnight travel by automobile, aircraft and train
    • Occasional weekend travel

Lead Product Development Engineer

Lead product development projects that involve internal and external personnel, and personally contribute to technical and administrative aspects of the design effort to ensure a high quality product that is delivered on schedule and within budget. The overall purpose is to design, develop and commercialize peripheral endovascular products that are in compliance with all applicable quality and regulatory requirements such as the Quality System Regulation (21 CFR Part 820, ISO13485), Risk Management (ISO14971).

Principle Responsibilities

  • Leading full life cycle development of catheter‐based peripheral vascular therapy from conceptualization, design, prototyping, testing, clinical evaluation, design verification, validation, management of key suppliers, and commercial market launch.
  • Work with Product Managers to assess clinical needs via physician interactions, developing design inputs and outputs, and developing iterations to meet customer requirements.
  • Project management and oversight of product development programs, include maintaining master project schedules.
  • Oversee internal and external engineering and manufacturing resources. Locate and establish working relationships with external resources as needed.
  • Use technical skills and sound judgment throughout the design process by contributing to hands‐on design, design reviews, and creation and review of technical documentation.
  • Support creation of solid models/drawings and manufacturing prototypes
  • Support pre‐clinical laboratory testing and animal studies including protocol development and generating final reports.
  • Lead Risk Management activities throughout the product life cycle. Makes deductions from varying facts or circumstances to make the determination regarding the acceptability of risks and utilize appropriate tools in the process (e.g. FMEA, Fault Tree analysis etc.).
  • Analyze and evaluate product defects and perform failure investigations to determine root cause, failure modes, and implement corrective and preventive actions and/or recommend modifications that lead to product and/or process enhancements.

The above statements are intended to describe the general level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities.

Job Requirements

  • Minimum of a BS in engineering (ideally mechanical or biomedical engineering)
  • 2‐3 years of project leadership experience
  • 8‐10 years of hands‐on product development experience, ideally in medical device product development.
  • Experience transitioning a product into manufacturing and distribution.
  • Knowledge of Quality Systems, Quality Assurance best practices, and Regulatory Compliance.
  • Experience ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF), or equivalent experience in a similarly regulated environment.
  • Experience with catheter and/or nitinol medical devices.

Additional Skills

  • Hands‐on team player with the ability to work in a fast paced, dynamic start‐up environment.
  • Experience working with small cross‐function product/process development teams.
  • Able to generate and communicate project strategies and scenario plans to team members, management, board members, etc.

Special Requirements

Risk Management:

  • Knowledge of risk management techniques and experience appropriate to perform risk management tasks in a regulated medical device development environment.

Environmental Situation:

  • General office environment
  • Laboratory environment
  • Domestic and international travel
  • Medical device research and manufacturing environment

Physical Functionality:

  • Includes varying work schedule
  • Prolonged periods of sitting, standing and walking
  • Travel by automobile, train and aircraft
  • Occasional travel on weekends