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Remote Quality Engineer Medical Device Jobs in Indiana

... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ... Quality management experience including significant participation in third party quality audits

... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ... Quality management experience including significant participation in third party quality audits

... engineering or medical physics. * Thorough knowledge of Medical Device regulation; at minimum an ... LI-REMOTE #LI-SC2 About Us BSI is a business improvement and standards company and for over a ...

... engineering or medical physics. * Thorough knowledge of Medical Device regulation; at minimum an ... LI-REMOTE #LI-SC2 About Us BSI is a business improvement and standards company and for over a ...

... device, and pharmaceutical organizations of all sizes to confidently advance scientific ... With deep domain expertise in regulatory sciences, clinical research solutions, quality ...

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Remote Quality Engineer Medical Device information

What does a Remote Quality Engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

What are the key skills and qualifications needed to thrive as a Remote Quality Engineer in Medical Devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

How do Remote Quality Engineers in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.
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 job categories do people searching Remote Quality Engineer Medical Device jobs in Indiana look for? The top searched job categories for Remote Quality Engineer Medical Device jobs in Indiana are:
What cities in Indiana are hiring for Remote Quality Engineer Medical Device jobs? Cities in Indiana with the most Remote Quality Engineer Medical Device job openings:
Infographic showing various Remote Quality Engineer Medical Device job openings in Indiana as of June 2026, with employment types broken down into 47% Full Time, 19% Part Time, and 34% Contract. Highlights an 100% Remote job distribution.
Senior Software Engineer for Medical Device Startup

Senior Software Engineer for Medical Device Startup

Levisonics

Fishers, IN โ€ข On-site, Remote

$114K - $151K/yr

Other

Medical, Dental, Vision, PTO

Posted 24 days ago


Job description

Senior Software Engineer

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

The key responsibilities include:

  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.
  • Software packaging and security.
    • Secure the code to prevent reverse engineering.
    • Package the software into executable files for easy installation and deployment.
  • 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.
  • Health data security.
    • Ensure the highest level of security for software and health data management.
  • 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.
  • 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.
  • 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