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Medical Device Validation Engineer Jobs in Indiana

Flotec

Be Seen First

Machinist / Inspector - Medical Device Manufacturing

Avon, IN · On-site

$40K - $55K/yr

Read and interpret engineering drawings, work instructions, inspection plans, routings, and manufacturing documentation. * Verify dimensional accuracy, surface finish, threads, features, and critical ...

INCOG

Senior Process Validation Engineer

Fishers, IN

$97K - $125K/yr

TSMS - Senior Process Validation Engineer The Senior Process Validation Engineer - Technical ... device assembly) processes - Strong understanding of 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 ...

Flotec

Be Seen First

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 ...

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 ...

Smart Tech

Manufacturing Engineer

Indianapolis, IN · On-site

$80K - $105K/yr

That is a major clue this may be medical device or regulated manufacturing. 6. ISO 9001 / ISO 13485 ... validation, ISO 13485, PFMEA, control plans, fixtures/tooling, soldering/epoxy, and Lean/CA ...

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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.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can reach or exceed a $500,000 annual salary, especially with experience, advanced skills, and leadership roles. Medical Device Validation Engineers typically earn less, but senior-level professionals with extensive expertise and certifications may approach high six-figure incomes in certain industries or companies.

How much does a validation engineer make at Pfizer?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. Salaries may also include benefits such as health insurance and bonuses, with some roles requiring knowledge of validation protocols and regulatory standards.

Are validation engineers in demand?

Validation engineers, including those in the medical device industry, are in high demand due to strict regulatory requirements and the need for quality assurance. Their skills in validation protocols, risk management, and compliance with standards like ISO 13485 and FDA regulations make them valuable in manufacturing and quality assurance roles across healthcare and biotech sectors.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that vary based on experience, location, and certifications. They often require knowledge of regulatory standards and validation tools, which can influence compensation levels. Overall, validation engineering is considered a well-paying profession within engineering fields.

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, and why are they important?

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
Senior Quality Engineer, Validation

Senior Quality Engineer, Validation

Cardinal Health, Inc.

Indianapolis, IN • On-site

$84K - $114K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Cardinal Health rating

7.7

Company rating: 7.7 out of 10

Based on 330 frontline employees who took The Breakroom Quiz

158th of 886 rated healthcare providers

Job description

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.
What a Sr. Quality Engineer contributes to Cardinal Health
  • Schedule, execute, and evaluate scientifically and statistically sound qualification experiments complying with all regulatory requirements.
  • Assure entire process and required inputs function in a consistent and repeatable manner, and comply with regulatory requirements, product license requirements, and policies affecting final product integrity.
  • Coordinates schedules involving manufacturing equipment to maximize equipment utilization.
  • Prepares documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria.
  • Provides technical support to various departments as needed.
  • Develops policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements.

Accountabilities
  • Conducts & develops validation and qualification protocols, projects and studies supporting manufacturing facility start-up and operation. Validation documentation to ensure products are manufactured in accordance with cGMP, pharmaceutical regulatory agencies, manufacturer, and Cardinal Health specifications/requirements.
  • Maintains close contact with various functions to assure effective communication on challenges and opportunities related to validation.
  • Provides technical support as needed.
  • Develops policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements regarding validation.
  • Supports the facility in internal and external regulatory inspections.
  • Works directly with management, contract customers, and/or contract engineers.
  • Maintain effectiveness of the Quality System components relevant to this position.
  • Works autonomously with minimal supervision.
  • Develops, maintains, and enforces Cardinal Health compliance standards.
  • Learns and carries out laboratory procedures or operate equipment as needed to perform qualification testing.
  • Performs other job duties as assigned.

Qualifications
  • Bachelor's degree in Chemical Engineering, Mechanical Engineering, Chemistry, Metrology or related science field, or equivalent work experience preferred
  • 2 or more years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
  • Experience with equipment qualification, software validation, test method validation, and/or process validation.
  • Validation and Technology Transfer process and experience with writing procedures/ reports and execution of laboratory test.
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
  • Preferred: Experience working with radiopharmaceuticals

Performance Expectations
  • Demonstrates a commitment to the organization's mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
  • Works as part of a team with others and shows respect and values diversity toward others.
  • Demonstrates efforts to discovering, meeting and advocating for the customer's needs.
  • Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
  • Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
  • The ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

What is expected of you and others at this level
  • Develops processes and procedures to implement functional strategies.
  • Role models Cardinal Health's high ethical standards and code of conduct.
  • Builds confidence and respect of others through a positive and energizing style.
  • Interprets internal/external business issues and adapts work priorities in own area.
  • Strives for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work.
  • Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view.
  • Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the Indy manufacturing site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

Anticipated salary range: $68,500.00-$97,800.00
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
  • Medical, dental and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before pay day with myFlexPay
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-Life resources
  • Paid parental leave
  • Healthy lifestyle programs

Application window anticipated to close: 8/17/2026
*if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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What Cardinal Health employees say

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About Cardinal Health

Sourced by ZipRecruiter

Cardinal Health Innovative Delivery Solutions With over 45 years of experience in helping hundreds of hospital and outpatient pharmacies, we provide access to best practice strategies and tactics to control costs, improve workflow and enhance safety. Cardinal Health Innovative Delivery Solutions is one of the largest employers of acute-care pharmacist in the United States. Cardinal Health is the employer of choice for pharmacists because we offer a variety of career opportunities in pharmacy leadership, clinical specialties, remote order entry, business management, medication therapy management and more.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Dublin, OH, US

Year founded

1971

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