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Medical Device Validation Engineer Jobs in Indiana

Voto Consulting LLC

Validation Engineer

Lebanon, IN · On-site

Position- Senior Validation Engineer, Local Type- ONSITE Location- Lebanon, IN Visa- GC Key ... Troubleshoot hardware, software, network, and field device issues. * Optimize system performance ...

Valspec

Validation Engineer

Indianapolis, IN · On-site

VALIDATION ENGINEER Location: Indianapolis, IN (AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY ... Premium medical coverage * 401(k) with company match * Tuition reimbursement * Unique performance ...

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Medical Device Validation Engineer information

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 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.

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 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 May 2026, with employment types broken down into 5% Internship, 71% Full Time, 5% Part Time, and 19% Contract. Highlights an 85% In-person, 5% Hybrid, and 10% Remote job distribution.

Manufacturing Engineer II - Medical Device Validation

Dexian

Highland, IN • On-site

$40 - $43/hr

Full-time

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

Job description

Job Title : Manufacturing Engineer II – Medical Device Validation

Location : Highland , IN

Pay range : $40 - $43

Duration : 12+ MONTHS

Job Description

We are seeking a motivated Manufacturing Engineer II to support manufacturing operations within a fast-paced, FDA-regulated medical device environment. This role is responsible for supporting manufacturing process improvements, validation activities, production support, and continuous improvement initiatives to ensure operational efficiency, product quality, and compliance with engineering and regulatory standards.

The ideal candidate will have experience in manufacturing engineering, process support, validation, and troubleshooting within regulated manufacturing environments. Candidates with medical device manufacturing and IQ/OQ/PQ validation experience are strongly preferred.

Key Responsibilities

Manufacturing & Process Support

  • Support daily manufacturing operations and production line performance improvements.
  • Monitor and improve OEE metrics including uptime, quality, performance, scrap reduction, and material usage variance (MUV).
  • Serve as a technical resource for manufacturing production lines and process troubleshooting.
  • Support implementation of continuous improvement initiatives for manufacturing processes and products.
  • Conduct root cause investigations and recommend corrective actions and technical solutions.

Validation & Quality Support

  • Support process and equipment validation activities including IQ/OQ/PQ protocols and execution.
  • Assist with CAPA investigations, corrective actions, and documentation deliverables.
  • Collaborate with Quality Engineering teams on qualification and process validation activities.
  • Ensure compliance with engineering documentation practices and FDA-regulated manufacturing standards.

Engineering & Project Support

  • Support engineering projects and ensure milestones are completed on time and within budget.
  • Develop and update manufacturing documentation, work instructions, and technical reports.
  • Assist with process characterization, tooling improvements, and manufacturing optimization projects.
  • Support training activities related to manufacturing procedures, equipment usage, and documentation practices.

Data Analysis & Continuous Improvement

  • Perform technical analysis and problem-solving activities to support production and process reliability.
  • Utilize engineering methodologies such as Six Sigma, DOE, Process Capability, and Gage R&R.
  • Participate in process optimization, automation, and manufacturing efficiency initiatives.
  • Contribute to long-term engineering projects and operational improvement strategies.

Qualifications

  • Bachelor's degree in engineering, Technology, or related STEM discipline required.
  • 2–4+ years of manufacturing engineering experience preferred.
  • Experience in regulated manufacturing environments strongly preferred.
  • Validation experience (IQ/OQ/PQ) highly preferred.
  • Knowledge of FDA QSR regulations and medical device manufacturing is a plus.
  • Experience with process improvement, CAPA, root cause analysis, and technical documentation.
  • Familiarity with automation, plastic injection molding, assembly processes, fixturing, and testing techniques preferred.
  • Working knowledge of Six Sigma methodologies and engineering analysis tools.
  • Experience with SolidWorks and mechanical/tooling concepts preferred.
  • Strong communication, organizational, and problem-solving skills.
  • Must be able to work onsite and support facility transition activities as needed.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

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