Sr Validation Engineer

Viant Medical Inc.; Indianapolis (IN); Presencial; USD 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

Multitasking

Communication

Regulatory knowledge

Educación

Bachelor's degree in Engineering or related field

Descripción del empleo

Join our team and produce products that save and enhance lives!

Shift Hours: Monday-Friday, First Shift; Onsite Full-Time Position.

Position Summary: The primary purpose of this job is to provide Validation/Quality Engineering support for operations to ensure Quality System and Medical Device Regulatory requirements are adhered to. This is an independent contributor role that requires the ability to work autonomously and manage multiple tasks effectively.

Mission: We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, vision benefits, and much more
• Company-paid life insurance and disability benefits
• 401K with company match
• 17 days of paid time off (pro-rated) and 10 paid Holidays

Responsibilities

• Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (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 the completion and maintenance of risk analysis to identify and mitigate potential product quality risks.
• Lead the generation and completion of validation protocols and reports for manufacturing equipment/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 the 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.

Education

• Bachelor’s Degree preferred in Engineering or related field
• General understanding of manufacturing equipment/process, software, and test equipment validations.

Experience

• Minimum 5+ years' experience as a Validation/Quality Engineer in Medical Device or Regulated Industry.

Skills/Competencies

• Ability to multitask and drive deliverables to completion.
• Good communication skills and ability to align with key stakeholders.
• Working knowledge in the interpretation and application of relevant Regulations and Industry Standards (e.g., FDA 21CFR820/QMSR, ISO13485, ISO14971).

Physical

• Light physical activity performing non-strenuous day-to-day activities of an administrative nature.
• Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing.
• Manual dexterity sufficient to reach and handle items.
• Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e., visualize objects of multiple dimensions), and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.).