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Quality Engineer Medical Device Jobs in Indiana (NOW HIRING)

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience in the medical device industry * Self-starter with the ability to identify improvement ... supplier quality and process engineering functions. * Proficiency with Microsoft Office ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience in the medical device industry Self-starter with the ability to identify improvement ... quality and process engineering functions. Proficiency with Microsoft Office applications ...

Zimmer, Inc.

Quality Sr Engineer II

Warsaw, IN · Hybrid

$89K - $112K/yr

CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred. * 5-7 years experience in a Quality Engineering role within the medical device ...

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 ...

OrthoPediatrics Corp.

Quality Engineer

Warsaw, IN · On-site

$60K - $78K/yr

Strong working knowledge of medical device quality system regulations and standards (e.g. 21CFR820 ... Engineering, Engineering Technology or related field. ASQ certification preferred. Must have ...

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Quality Engineer Medical Device information

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

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

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.

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

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

More about Quality Engineer Medical Device jobs

What are the most commonly searched types of Quality Engineer Medical Device jobs in Indiana?

The most popular types of Quality Engineer Medical Device jobs in Indiana are:

What are popular job titles related to Quality Engineer Medical Device jobs in Indiana?

For Quality Engineer Medical Device jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Device jobs in Indiana look for?

The top searched job categories for Quality Engineer Medical Device jobs in Indiana are:

Infographic showing various Quality Engineer Medical Device job openings in Indiana as of September 2026, with employment types broken down into 2% As Needed, 77% Full Time, 15% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution.

Embedded Systems Engineer for Medical Device Startup

Fishers, IN • On-site

Levisonics, Inc.
1 - 10 employees
Learn more about Levisonics, Inc.external

Full-time

Medical, Dental, Vision, PTO

Re-posted 16 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.
Job Summary: We are seeking a talented and experienced Embedded Systems Engineer to join our team and lead the design and development of embedded computing systems, guiding our devices from prototypes to commercial readiness. The ideal candidate will have a Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or a related field, with at least 5 years of experience (Ph.D. preferred). You will drive embedded hardware/software development for real-time systems, emphasizing proficiency in C, C++, and/or assembly language for hardware interfacing and optimization. Experience in hardware architectures, sensors, actuators, and communication protocols is crucial, alongside a knack for evaluating and selecting optimal components. Hands-on experience with embedded processors and display integration, as well as a strong grasp of design modification processes to enhance device durability, are also required. Proficiency in coding and optimizing for resource-constrained environments is a plus. As the first embedded engineer on our team, you will play a pivotal role in advancing our blood coagulation testing device from prototype to production. This role is critical to the success of our product and involves working on multiple federal grants and projects. You will be responsible for both hardware and software components, ensuring our device is efficient, reliable, and ready for market.
Startup Environment: Operating in a fast-paced startup, we value innovation, adaptability, and proactive mindsets. Ideal team members thrive under pressure, manage multiple projects, and adapt as company needs evolve. 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. 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. Design & build portable battery system for power supply.
  2. Improve sample handling system design.
  3. Implement an independent embedded processing system and streamlined user interface for straightforward operation.
  4. Upgrade embedded processing system.
  5. Develop efficient injection/fluid handling systems.
  6. Identify and implement efficient computing by selecting and implementing embedded computers to run inside the medical device.
  7. Ensure the embedded system replaces the laptop.
  8. Integrate various hardware and software components together.
  9. Enable battery operation of the device.
  10. Design and develop sample handling systems and cartridges.
  11. Lead end-to-end projects for multiple federal grants and develop innovative solutions.
  12. Collaborate with other team members in taking device prototypes to market.
  13. Participate in FDA-related activities and follow quality protocols.
  14. Participate in grant writing or other fundraising activities as needed.
  15. Perform other relevant tasks as needed for the company.

Minimum Qualifications:
  • Bachelors in Electrical Engineering, Computer Engineering, or a related field and minimum 5 years of experience.
  • Proven experience in embedded systems engineering, preferably in the medical device industry.
  • Knowledge of sensors and commercial medical devices.
  • Proficiency in C, C++, and/or assembly language for embedded software development.
  • Experience with battery systems, fluid handling systems, and embedded processing systems.
  • Familiarity with CAD design, particularly using software like SolidWorks.
  • Understanding of calibration techniques.
  • Familiarity with injection molding and 3D printing for rapid prototyping.
  • Ability to design devices for manufacturing at scale.
  • Knowledge of cybersecurity as it relates to medical devices.
  • Familiarity with rheology/acoustics topics is a plus.
  • Strong problem-solving and analytical skills.
  • Ability to learn new concepts proactively and break down work effectively.
  • Familiarity with Agile methodologies and efficient project management.
  • Demonstrated accountability, effective planning, and team leadership.
  • Innovative thinker with a track record of generating new ideas.
  • Strong written and verbal communication skills.

Preferred Qualifications:
  • Masters or Ph.D. in Electrical Engineering, Computer Engineering, or a related field.
  • Experience selecting and implementing embedded processors and displays.
  • Prior startup or medical device development experience
  • Experience in medical device 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