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Project Engineer - Risk Management in Pharma/Med Device

Verista, Inc.Indianapolis, IN
On-site Full-time $80.5K/yr - $114.4K/yr

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Experience Level

Experience

Qualifications

Bachelor's degree in engineering or a related field preferred; experience in risk management and familiarity with ISO 14971 standards is advantageous.

About the job

Description

Verista boasts a team of 500 experts dedicated to partnering with some of the most recognized brands in the life sciences sector to address their business challenges. Our mission is to foster growth and innovation within the scientific community, aiding researchers, organizations, and companies in tackling some of the most critical healthcare issues globally. We offer innovative solutions and services that enable informed decision-making, backed by substantial investments in our talented workforce and capabilities.

Our growth is fueled by exceptional individuals who thrive in collaborative environments and share our commitment to enhancing the lives of our life sciences clients. Our devoted professionals strive to make a meaningful impact each day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues.
  • We are dedicated to achieving client success at every opportunity.
  • We have the courage to uphold integrity.
  • We promote an inclusive atmosphere where all colleagues feel valued, engaged, and challenged.
  • We continually seek to learn and grow from our experiences to enhance our collective expertise.

Job Summary:

We are looking for a Risk Management Engineer to join our IDM Risk Management Turbo AC team. This role involves creating and continually improving risk management deliverables in accordance with ISO 14971, assisting in the migration of FMEAs from existing software, and serving as a subject matter expert for the Turbo AC Software System.

Your collaboration with engineering, manufacturing, quality, and human factors teams will be essential to ensure that the setup and structure of the FMEAs adhere to Client SOPs and ISO 14971 standards.

Key Responsibilities:

  • Assist in the development and execution of risk management deliverables that comply with ISO 14971.
  • Act as a subject matter expert for the Turbo AC Software System.
  • Facilitate and document the migration of FMEAs from an existing software system to Turbo AC.
  • Conduct working sessions to guide teams on utilizing the Turbo AC Software System effectively.
  • Document bugs and recommend upgrade features for the Turbo AC Development team.
  • Create and execute test scripts to support Turbo AC upgrade validation.
  • Collaborate with cross-functional teams, including Systems Engineering, Manufacturing, and Human Factors.

About Verista, Inc.

Verista, Inc. is a leading firm in the life sciences sector, committed to driving innovation and providing comprehensive solutions that empower clients to navigate complex healthcare challenges. Our dedicated team of professionals is focused on making a positive impact in the industry.

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