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6001 - Project Engineer / Risk Management (Pharma/Med Device)

Indianapolis, IN

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

  • Support the development and deployment of risk management deliverables in alignment with ISO 14971
  • Serve as subject matter expert for the Turbo AC Software System
  • Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
  • Conduct working sessions to guide teams on how to use the Turbo AC Software System
  • Document bugs and tangible upgrade features to share with the Turbo AC Development team
  • Creating and Running test scripts to support Turbo AC upgrade Validation
  • Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
  • Create/update standard operating procedures

Qualifications:

  • Bachelor’s degree in engineering, biomedical, systems, or related field
  • 3-5 years of experience in medical device development or risk management
  • Knowledge of ISO 14971
  • Experience creating and reviewing FMEAs and other risk tools
  • Strong organizational and communication skills, especially in cross-functional settings
  • Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

  • Experience with risk management tools like TurboAC or QMSpace
  • Familiarity with the design control processes under FDA and EU MDR frameworks
  • Experience with Change Control Trackwise or Veeva OneQMS

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$80,465 - $114,429 USD

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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