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Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest!
We are looking for a C# Python Developer to join our growing team in Indianola, PA (on-site).
Top 3 Must Haves
We are seeking a skilled C# and Python Developer to join our team in the medical device domain. The ideal candidate will have hands-on experience developing and testing software for medical devices, with a strong focus on compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304). This role involves working closely with cross-functional teams to develop, validate, and maintain high-quality, reliable software for class II and III medical devices.
Key Responsibilities
Software Development:
Ensure adherence to medical device standards such as IEC 62304, ISO 14971, and FDA guidelines for software development and validation.
Document code, design, and validation processes to meet regulatory requirements.
Testing And Validation
Develop and execute unit tests, integration tests, and system-level tests.
Conduct requirement validation, test case development, and test coverage analysis using shift-left and AI-driven techniques.
Perform automated and manual testing to ensure device safety and efficacy.
Collaboration
Work closely with system architects, quality assurance teams, and regulatory professionals.
Provide support during design reviews, audits, and regulatory submissions.
Continuous Improvement
Optimize existing software for performance, scalability, and maintainability.
Stay updated on emerging trends and best practices in software development for medical devices.
Qualifications
Required Skills:
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or a related field.
Minimum 5-7 years of experience in software development for medical devices or a regulated domain.
Benefits
Why QualiTest?
We are looking for a C# Python Developer to join our growing team in Indianola, PA (on-site).
Top 3 Must Haves
- Proficiency in C# and Python programming languages.
- Strong understanding of object-oriented programming (OOP) principles and software design patterns.
- medical domain (hands-on experience developing and testing software for medical devices, with a strong focus on compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304)
We are seeking a skilled C# and Python Developer to join our team in the medical device domain. The ideal candidate will have hands-on experience developing and testing software for medical devices, with a strong focus on compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304). This role involves working closely with cross-functional teams to develop, validate, and maintain high-quality, reliable software for class II and III medical devices.
Key Responsibilities
Software Development:
- Design, develop, and maintain robust software infrastructure solutions using C# and Python for medical devices.
- Implement features and functionality to support diagnostic, monitoring, and therapeutic medical systems.
Ensure adherence to medical device standards such as IEC 62304, ISO 14971, and FDA guidelines for software development and validation.
Document code, design, and validation processes to meet regulatory requirements.
Testing And Validation
Develop and execute unit tests, integration tests, and system-level tests.
Conduct requirement validation, test case development, and test coverage analysis using shift-left and AI-driven techniques.
Perform automated and manual testing to ensure device safety and efficacy.
Collaboration
Work closely with system architects, quality assurance teams, and regulatory professionals.
Provide support during design reviews, audits, and regulatory submissions.
Continuous Improvement
Optimize existing software for performance, scalability, and maintainability.
Stay updated on emerging trends and best practices in software development for medical devices.
Qualifications
Required Skills:
- Proficiency in C# and Python programming languages.
- Strong understanding of object-oriented programming (OOP) principles and software design patterns.
- Experience with software development lifecycle (SDLC) in regulated environments.
- Knowledge of IEC 62304 and other relevant medical device software standards.
- Familiarity with tools like Git, JIRA, Azure DevOps, or similar for version control and project management.
- Exposure to SQUISH and TOSCA tools would be added advantage.
- Experience with software and system-level testing for Class II and Class III medical devices.
- Knowledge of communication protocols such as USB, BLE, or TCP/IP.
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or a related field.
Minimum 5-7 years of experience in software development for medical devices or a regulated domain.
Benefits
Why QualiTest?
- Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
- Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
- Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
- Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers. Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
- Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
- Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
- Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
- Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
- We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
- Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
- A Competitive pay, the salary range for the role is $90,000 - $100,000.
- Intrigued to find more about us?
- Visit our website at https://www.qualitestgroup.com/
- If you like what you have read, send us your resume and let’s start talking!
Key Skills
Ranked by relevance
python
c
oop
ai
design patterns
devops
jira
git
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- Posted
- Feb 04, 2025
- Type
- Full-time
- Level
- Entry
- Location
- Kingston
- Company
- Qualitest
Industries
IT Services
IT Consulting
Categories
Engineering
Information Technology
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