Sr Validation Engineer

Viant•Indianapolis, IN

5d•Onsite

About The Position

The Sr Validation Engineer provides Validation and Quality Engineering support for operations to ensure compliance with the Quality System and medical device regulatory requirements. This independent-contributor role requires working autonomously and managing multiple tasks effectively. The role leads the validation program for Viant Medical’s Indianapolis manufacturing site and supports compliance with regulatory, notified body, and customer requirements. The position is onsite, full-time, Monday through Friday on first shift.

Requirements

Minimum 5+ years of experience as a Validation/Quality Engineer in the medical device or another regulated industry.
General understanding of manufacturing equipment/process, software, and test equipment validations.
Ability to multitask and drive deliverables to completion.
Good communication skills and ability to align with key stakeholders.
Working knowledge of interpreting and applying relevant regulations and industry standards, such as FDA 21 CFR 820/QMSR, ISO 13485, and ISO 14971.
Ability to perform light physical activity, including minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing.
Manual dexterity sufficient to reach and handle items.
Ability to identify and distinguish colors, judge distance and spatial relationships, visualize objects of multiple dimensions, and adjust eye focus to bring objects into sharp focus, such as when using a microscope.

Nice To Haves

Bachelor’s degree in Engineering or a related field preferred.

Responsibilities

Adhere to Viant Core Beliefs and all safety and quality requirements, including Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA regulations, company policies and operating procedures, and other regulatory requirements.
Lead the validation program for the Viant Medical Indianapolis Manufacturing Site, ensuring compliance with regulatory, notified body, and customer requirements.
Support regulatory, notified body, and customer inspections, audits, investigations, and inquiries.
Monitor validation activities in accordance with the Validation Master Plan (VMP) and periodic review requirements.
Lead and implement procedural updates concerning the validation program.
Support completion and maintenance of risk analyses to identify and mitigate potential product quality risks.
Lead the generation and completion of validation protocols and reports for manufacturing equipment and processes, and test and measurement equipment.
Collaborate with Manufacturing Engineers, Supply Chain, and Operations to coordinate validation activities.
Communicate and interact effectively with customers.
Lead or support capability studies and the application of statistical techniques.
Support preparation of control plans, including inspection, test, and gauge requirements.
Operate with a high level of integrity and initiative, committed to achieving goals and objectives.
Perform other functions as required.