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Medical Device Quality Jobs in Indiana (NOW HIRING)

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Software Quality Engineer Warsaw, IN Hybrid role (3 days in office) $55 - $64 per hour ABOUT THE ... Support the design, development, and testing of medical device software, including Software as a ...

BSI Prof Serv EHS West

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

BSI Group

Knowledge of medical device regulations ... Awareness of certification business processes, the application of quality management standards, and ...

OrthoPediatrics Corp.

Quality Engineer

Warsaw, IN · On-site

$70 - $95/hr

Strong working knowledge of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971) EDUCATION AND/OR EXPERIENCE Requires a Bachelor degree in Industrial ...

OrthoPediatrics

Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

... of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971) EDUCATION AND/OR EXPERIENCE: Requires a Bachelor degree in Industrial Engineering, Industrial ...

CTE Solutions

Senior Quality Engineer

Plymouth, IN · On-site

$95 - $130/hr

Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Reviewing and ... Strong background in quality control and quality engineering functions * Understanding GD&T

CTE Solutions

Senior Quality Engineer

Plymouth, IN · On-site

$80K - $109K/yr

Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements * Reviewing and ... Strong background in quality control and quality engineering functions * Understanding GD&T

Hearst

Medical Coder Specialist

Carmel, IN · On-site

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

Hearst Health

Medical Coder Specialist

Carmel, IN · On-site

First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from the FDA, device manufactures, and other credible ...

First Databank

Medical Coder Specialist

Carmel, IN

Are you ready for this exciting challenge? _____ First Databank (FDB) is currently seeking a Medical Device in the Quality department. This position is responsible for researching data published from ...

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Medical Device Quality information

See Indiana salary details

$20

$34

$67

How much do medical device quality jobs pay per hour?

As of Sep 3, 2026, the average hourly pay for medical device quality in Indiana is $34.94, according to ZipRecruiter salary data. Most workers in this role earn between $23.56 and $43.70 per hour, depending on experience, location, and employer.

What is medical device quality?

Medical Device Quality refers to the processes and standards used to ensure that medical devices are safe, effective, and comply with regulatory requirements throughout their lifecycle. Professionals in this field oversee quality management systems, conduct inspections, manage documentation, and ensure that products meet both company and government standards. Their work helps prevent defects, maintains patient safety, and supports compliance with agencies like the FDA and ISO standards.

What does a medical device quality professional do?

Professionals in Medical Device Quality are typically responsible for ensuring that products meet regulatory standards and company quality requirements. Daily tasks often include reviewing and updating quality documentation, conducting audits, analyzing data from quality tests, and collaborating with manufacturing and engineering teams to resolve any issues. They also play a key role in managing non-conformances, implementing corrective actions, and supporting continuous improvement initiatives. Regular communication with regulatory bodies and staying updated on compliance requirements are also common aspects of the role.

What are the key skills and qualifications needed to thrive as a medical device quality professional?

To thrive as a Medical Device Quality professional, you need expertise in quality assurance, regulatory compliance (such as FDA and ISO 13485), and strong analytical skills, typically backed by a degree in engineering or a related field. Familiarity with quality management systems (QMS), risk management tools, and validation processes is essential, as are certifications like ASQ CQE or Six Sigma. Attention to detail, problem-solving, and effective communication are critical soft skills for ensuring product safety and collaborating across teams. These competencies help ensure that medical devices meet stringent regulatory standards and maintain patient safety and company reputation.

What is the difference between Medical Device Quality vs Medical Device Regulatory Affairs?

AspectMedical Device QualityMedical Device Regulatory Affairs
CertificationsISO 13485, Six Sigma, CQERegulatory affairs certifications, RAC, ISO 13485 familiarity
Work EnvironmentQuality departments, manufacturing sites, labsRegulatory agencies, corporate offices, compliance teams
Industry UsageEnsures product quality, compliance with standardsManages regulatory submissions, compliance with laws

Medical Device Quality focuses on maintaining product standards and compliance through quality management systems, while Medical Device Regulatory Affairs handles regulatory submissions and ensures products meet legal requirements. Both roles are essential in bringing safe, compliant medical devices to market, but they emphasize different aspects of the product lifecycle.

What cities in Indiana are hiring for Medical Device Quality jobs?

Cities in Indiana with the most Medical Device Quality job openings:

Medical Device Quality jobs near you
Infographic showing various Medical Device Quality job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, and 5% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $72,685 per year, or $34.9 per hour.

Senior Software Engineer for Medical Device Startup

Levisonics, Inc.

Fishers, IN • On-site

$114K - $151K/yr

Full-time

Medical, Dental, Vision, PTO

Re-posted 13 days ago

Job description

About Us:
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Our full-time team currently comprises a CEO/Biomedical Engineer, and an Electrical Engineer.
Job Summary:
We are seeking a talented and experienced Senior Software Engineer to join our team and lead the development and optimization of software workflows for our innovative acoustic tweezing technology-based medical devices. The ideal candidate will have a Master's degree in Computer Science, Software Engineering, or a related field, with a minimum of 5 years of experience. This role requires strong coding skills in Python and C/C++, proficiency in developing intuitive and visually engaging graphical user interfaces, and expertise in SQL for effective data management and database design. Experience with version control systems, particularly Git, is essential, along with the ability to understand and generate code from workflow diagrams. As the first and only software engineer on the team, you will play a pivotal role in shaping the software development efforts for our groundbreaking technology. This role is critical to the success of our product and involves working on multiple federal grants and projects.
Startup Environment:
We operate in a fast-paced startup environment where innovation, adaptability, and a proactive mindset are key to success. We are looking for individuals who are passionate about working in a startup setting and thrive in dynamic and challenging situations. We value individuals who are not just seeking a job but are driven by a genuine passion for creating impactful solutions and driving change in the medical device industry. Our team members are expected to work well under pressure, juggle multiple projects, and be flexible in their roles as the needs of the company evolve. If you are excited about the opportunity to make a meaningful impact and are ready to roll up your sleeves and tackle challenges head-on, we encourage you to apply.
Key Responsibilities:
  1. Optimize and Enhance Existing Software:
  • Improve the efficiency of our existing software written in Python.
  • Increase processing speed for short-term operation on laptops.
  • Convert and optimize the software for embedded computing devices inside the medical device long-term.
  1. Software Packaging and Security:
  • Secure the code to prevent reverse engineering.
  • Package the software into executable files for easy installation and deployment.
  1. Connectivity and Data Management:
  • Ensure the software can connect to the internet.
  • Implement connectivity to an online database for long-term data management.
  • Incorporate Data Science, Machine Learning, and AI for handling large amounts of health data.
  1. Health Data Security:
  • Ensure the highest level of security for software and health data management.
  1. New Technique Development:
  • Convert and develop existing crude MATLAB codes and technology algorithms into efficient software for commercial use.
  • Create executable files with efficient large data handling capabilities.
  • Develop complex data processing software and manage large data analysis.
  • Develop a user-friendly interface for healthcare professionals.
  • Implement a remote kill switch for the software.
  • Apply all relevant requirements from existing software.
  1. Parallel Processing and Language Conversion:
  • Implement efficient parallel processing techniques.
  • Convert existing Python code to C/C++ or another suitable low-level efficient language to run software optimally on embedded hardware.
  1. Other Responsibilities:
  • Develop high-quality, efficient, and maintainable code.
  • Design intuitive and visually engaging user interfaces.
  • Proactively take on new responsibilities and suggest innovative ideas for product and company growth.
  • Participate in grant writing and fundraising activities.
  • Engage in FDA-related activities and adhere to quality protocols.
  • Perform other relevant software-related tasks as needed for the company.

Minimum Qualifications:
  • Master's degree in Computer Science, Software Engineering, or a related field.
  • Minimum of 5 years of experience in software development.
  • Strong coding skills in Python, C, and C++ (JavaScript is a plus).
  • Proficiency in developing intuitive and visually engaging graphical user interfaces.
  • Proficiency in SQL for effective data management and database design.
  • Experience with version control systems, particularly Git.
  • Ability to understand and generate code from workflow diagrams.
  • Knowledge of integrating multiple devices and establishing centralized control.
  • Familiarity with IDEs, preferably PyCharm.
  • Excellent problem-solving skills and ability to work independently.
  • Strong written and verbal communication skills.

Preferred Qualifications:
  • Experience working in the medical device industry.
  • Familiarity with Agile development methodologies.
  • Knowledge of machine learning techniques and algorithms.
  • Experience with Docker and containerization technologies.
  • Familiarity with cloud platforms such as AWS or Azure.
  • Prior experience working in startups.
  • Experience with embedded systems and medical device software development.
  • Strong knowledge of data security, especially related to health data.
  • Knowledge of parallel processing and algorithm optimization.
  • Innovative mindset with a track record of proactive contributions.
  • Experience in grant writing and regulatory compliance (FDA).

What We Offer:
  • Competitive salary
  • Health, dental, and vision insurance coverage
  • Generous paid time off
  • Professional development opportunities
  • Potential to receive stock options
  • Opportunities for growth within the company
  • Flexible work arrangements, including remote work options
  • Dynamic and innovative startup environment
  • Opportunity to make a meaningful impact in the medical device industry

Apply