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Medical Device Validation Engineer Jobs in Indiana

INCOG

Process Validation Engineer

Fishers, IN

TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process ... device assembly) processes - Interest in learning CMC regulatory requirements and process ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

Flotec

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based ... Support validation activities, including process validation, test method validation, equipment ...

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Medical Device Validation Engineer information

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in Indiana? For Medical Device Validation Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Indiana look for? The top searched job categories for Medical Device Validation Engineer jobs in Indiana are:
What cities in Indiana are hiring for Medical Device Validation Engineer jobs? Cities in Indiana with the most Medical Device Validation Engineer job openings:
Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in Indiana as of August 2026, with employment types broken down into 61% Full Time, 6% Temporary, and 33% Contract. Highlights an 94% In-person, and 6% Remote job distribution.

6321 - Validation Engineer / CQV Engineer - Change Control & Deviations

Verista, Inc.

Indianapolis, IN • On-site

$59K - $102K/yr

Full-time

Re-posted 9 days ago

Job description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:Change Control Management
  • Author, review, and manage change controls impacting systems, equipment, and processes
  • Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
  • Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
  • Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)
Deviation Management
  • Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
  • Ensure deviations are thoroughly documented, investigated, and closed within required timelines
  • Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations
CQV & Compliance Support
  • Device Assembly Packaging
  • Maintain alignment with cGMP and Good Documentation Practices (GDP)
  • Support validation impact assessments and execution activities related to changes
  • Review and approve validation and technical documentation as required
  • Participate in audits and inspections, providing SME support for change control and deviation processes
Cross-Functional Collaboration
  • Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams
  • Support continuous improvement initiatives related to quality systems and CQV processes
  • Communicate project status, risks, and issues to stakeholders
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or related field
  • 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry
  • Strong experience with:
    • Change control systems
    • Deviation investigations and root cause analysis
    • cGMP and GDP environments
  • Familiarity with device assembly/packaging operations is highly preferred
  • Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
  • Strong technical writing and documentation skills
  • Excellent communication and cross-functional collaboration abilities
  • Onsite job requirement in Indianapolis, IN

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range
$59,951—$102,623 USD

Benefits

Why Choose Verista?

  • 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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com