Senior Medical Systems Design Engineer

Location: Marlborough, MA
Salary: $130,000.00 USD Annually - $165,000.00 USD Annually
Description: We are seeking a talented and experienced Medical Systems Design Engineer to develop and integrate cutting-edge software and hardware solutions for our advanced endoscopic system. This role involves working with image processing, laser technology, and fluid management in surgical endoscopy. The successful candidate will have expertise in multiple technology stacks, such as C#, .Net Core, and DevOps tools, along with experience in managing video files and healthcare interfaces like DICOM and HL7.

This job will have the following responsibilities:

• Lead the development of complex medical instruments through all phases, from design input to manufacturing transfer.
• Develop and manage IP portfolios, providing innovative technical solutions to enhance performance, functionality, and cost-effectiveness.
• Collaborate with marketing, customers, other departments, and contracted companies to develop product specifications.
• Maintain relationships with third-party consultants, contractors, and suppliers, ensuring quality, timeline, and budget adherence.
• Ensure product designs meet global regulatory requirements for medical devices, including FDA regulations, ISO 13485, and CE mark.
• Assist in developing and maintaining design history files and other documentation to support regulatory approval and manufacturing.
• Design, develop, and maintain software solutions using various technology stacks, including C# and .Net.
• Develop and support integrations with patient information systems using HL7, DICOM, and FHIR interfaces.
• Write high-quality, secure, and maintainable code, ensuring platform reliability and scalability.
• Develop and maintain unit tests with high code coverage to ensure rigorous testing and performance optimization.
• Create clear and concise documentation, flowcharts, layouts, diagrams, and code comments for low-level design.
• Mentor and guide junior developers and consultants, performing code reviews to maintain overall architecture and code quality.
• Ensure compliance with policies and procedures for quality, security, and privacy, ensuring platform security and industry standard compliance.
• Collaborate with cross-functional teams to gather requirements and translate them into technical solutions.
• Communicate architecture, status, and risks to product managers, project managers, and other stakeholders.
• Develop and maintain technical product requirements, designs, and specifications.
• Provide support for problem resolution during development and post-product release.

Qualifications & Requirements:

• Minimum of 5+ years in Software Engineering, with experience working with internal and external teams, development partners, and suppliers under ISO 13485 and FDA protocols.
• Experience in creating documentation to support rapid prototyping for pre-clinical and clinical studies.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSRs, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366.
• Experience with healthcare interfaces.
• Strong background in object-oriented programming and design patterns.
• Proficiency in Microsoft technologies, including .NET Core and .NET Framework.
• Experience with service-oriented architecture (SOA) and containerized application development.
• Experience with API development using gRPC and HTTP/REST.
• Proficiency in one or more core languages: .NET, C#, JavaScript, TypeScript.
• Front-end experience with SPA frameworks such as Angular or React.
• Experience using Visual Studio as a development environment.
• Experience with SDLC, source control, configuration management, and continuous integration pipelines.
• Bachelor's degree in a related discipline, such as Computer Science, Electrical Engineering, or a related field; a master's degree is preferred.
• Strong knowledge of US and global regulatory requirements for medical devices.

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