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Verista · 1 day ago

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

Indianapolis, IN

Full-time

Onsite

Mid Level

$80K/yr - $114K/yr

3+ years exp

Verista is a company that partners with leading brands in the life sciences industry to address critical healthcare challenges. They are seeking a Risk Management Engineer to enhance risk management deliverables, support FMEA migration, and collaborate with various teams to ensure compliance with ISO 14971.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

ISO 14971FMEA creationRisk management toolsBiomedical engineeringMicrosoft OfficeCommunicationOrganizational skills

Required

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

Preferred

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

Benefits

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)