Lead Medical Device Validation Engineer

Viant Medical Inc.; Indianapolis (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Company-paid life insurance

Disability benefits

401K with company match

PTO 17 days (pro-rated) and 10 paid H"

Holidays 10

Job summary

Viant Medical Inc. in Indianapolis is seeking a Validation/Quality Engineer to support operations with adherence to QMS and FDA regulations.

The role requires autonomous work, leadership of validation activities, and collaboration with cross-functional teams to ensure high-quality medical devices. The position offers onsite full-time employment with benefits starting at hire, including medical/dental/vision, company-paid life insurance, disability benefits, a 401(k) with match, and paid time

Qualifications

• Bachelor’s Degree preferred in Engineering or related field.
• Minimum 5+ years' experience as a Validation/Quality Engineer in Medical Device or Regulated Industry.

Responsibilities

• Lead the Validation Program for the Viant Medical Indianapolis Manufacturing Site, ensuring regulatory and customer requirements.
• Support regulatory inspections, audits, investigations, and inquiries.
• Monitor validation activities per the Validation Master Plan (VMP) and periodic reviews.
• Lead procedural updates concerning the validation program.
• Assist with risk analysis to identify and mitigate product quality risks.
• Generate and close validation protocols and reports for manufacturing equipment/processes and test/measurement equipment.
• Collaborate with Manufacturing Engineers, Supply Chain, and Operations to coordinate validation activities.
• Communicate effectively with customers and key stakeholders.
• Support capability studies and application of statistical techniques.
• Assist in the preparation of control plans, including inspection, test, and gauge requirements.

Skills

Multitasking

Communication

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Viant Medical Inc. in Indianapolis is seeking a Validation/Quality Engineer to support operations with adherence to QMS and FDA regulations.

The role requires autonomous work, leadership of validation activities, and collaboration with cross-functional teams to ensure high-quality medical devices. The position offers onsite full-time employment with benefits starting at hire, including medical/dental/vision, company-paid life insurance, disability benefits, a 401(k) with match, and paid time