Senior Validation Engineer

Indianapolis, IN, US • Posted 12 hours ago • Updated 15 minutes ago
Full Time
Part Time
On-site
Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

  • Quality Management
  • Risk Management
  • Reporting
  • Root Cause Analysis
  • Corrective And Preventive Action
  • Risk Assessment
  • Change Control
  • QMS
  • Collaboration
  • Manufacturing
  • Regulatory Compliance
  • Continuous Improvement
  • Mechanical Engineering
  • Biomedicine
  • Medical Devices
  • IQ
  • OQ
  • PQ
  • Test Methods
  • FMEA
  • SANS
  • ISO 13485

Summary

Overview

We are supporting a prominent medical device manufacturer in expanding their engineering team for high-visibility mammography product lines. This position plays a key role in enhancing manufacturing validation processes, reinforcing quality systems, and ensuring compliance through strong risk management and validation practices.

Key Responsibilities

  • Review and strengthen existing PFMEAs by identifying failure modes, risk gaps, and improving mitigation controls.
  • Lead and execute Process Validation activities (IQ/OQ/PQ), including protocol authoring, execution, and final reporting.
  • Develop risk-based validation strategies and clearly define acceptance criteria with proper traceability to risk assessments.
  • Perform and document Test Method Validation (TMV) to ensure accuracy, reliability, and compliance
  • Drive deviation investigations, conduct root cause analysis, and implement effective corrective actions (CAPA).
  • Ensure proper linkage between risk assessments, validation activities, deviations, and change control within the QMS.
  • Collaborate with Manufacturing, Quality, and cross-functional teams to maintain regulatory compliance and support continuous improvement initiatives.

Qualifications

  • Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, or related)
  • 4 5+ years of medical device experience
  • Experience with established med device companies (e.g., Stryker, Johnson & Johnson)
  • Strong experience in Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV)
  • PFMEA and remediation experience preferred

Knowledge of FDA regulations and ISO 13485

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90737436
  • Position Id: OOJ - 8104-7108-1773409488
  • Posted 12 hours ago
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