Contract Project Manager – Design Assurance
Acist Medical Systems, Inc. - Eden Prairie, MN

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ACIST Medical Systems is the market leader in providing innovative diagnostic and therapeutic products and services that enable interventionalists and their clinical teams in providing superior patient care. Our focus is “the pursuit of the perfect image” through continuous research and development of new products and technologies – supporting today’s needs and anticipate those of tomorrow. We are an international company, with products in over 45 countries, providing high quality systems and award-winning customer support across the globe.

We believe employees are our greatest asset. ACIST fosters an environment that attracts and retains employees who are proactive, responsive and innovative through commitment to teamwork, communication, feedback and change.

Position Summary

ACIST Medical Systems is currently looking to bring on a Contract Project Manager to to assist with 60601-1 third edition project and Design Assurance.

Project Responsibilities

Duties: Project Manager; 60601-1 third edition

  • Prepare and submit documentation to electrical safety agency (UL, CSA, Intertek) for review and approval of medical device according to IEC 60601-1 third edition.
  • Work with engineering and QA to identify gaps in current risk management documentation, labeling, and user manuals and recommend and complete updates to satisfy third edition requirements.
Duties: Design Assurance

  • Serve as DA team member on product development teams to drive compliance and completeness of the medical device product development process. Activities include risk management, design verification and validation, and various levels of involvement with requirements, traceability, change control and documentation, and other project deliverables.
Length of assignment: 3-6 months

Required Skills

Design Assurance position: Minimum three years medical device experience in design assurance, product development, or project management.

IEC 60601-1 third edition position: experience with medical device approvals through CSA, UL, or comparable agency, with preference toward second edition, and stronger preference to third edition.

Required Experience

About this company
ACIST® Medical Systems is a global medical device company that develops advanced contrast injection technologies that help simplify the...