Senior Medical Systems Design Engineer

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

We are seeking a skilled and experienced Medical Systems Design Engineer, responsible for developing and integrating software / hardware solutions and products related to an Endoscope system with image processing, laser, and fluid management in surgical endoscopy. System integration includes image/video processing software and hardware, GUI interfaces, and data transfer between all devices in the system. Successful candidate must have expertise in multiple technology stacks, preferably C#, .Net Core and DevOps tools, subject matter expertise in managing video files, experience with healthcare interfaces, such as DICOM and HL7. You will be expected to be proficient individual contributor who can jump in and support project deliverables and find solutions to meet goals and schedules.

Responsibilities:

• Lead development of complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements;
• Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability costs requirements;
• Develop product specification in coordination with marketing, customers, other company departments, and contracted companies.
• Maintain business relationships with 3rd party consultants, contractors, and suppliers. Including correspondence when the quality, timeline, or budget are at risk;
• Sensitivity and awareness of both program budget and product costs including clinical economics.
• Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others;
• Assist in development and maintaining of design history file and other documentation to support product regulatory approval and manufacture.
• Design, develop and maintain software solutions using variety of technology stacks, including C#, and .Net.
• Develop and support solutions for integrating with patient information systems, using HL5, DICOM, FIHR interfaces.
• Write high-quality, secure, and maintainable code to deliver on agile user stories, ensuring that our platform is reliable and scalable.
• Develop and maintain unit tests with high a high degree of code coverage, ensuring that our code in rigorously testing and optimized for performance.
• Create clear and concise documentation, flowcharts, layouts, diagrams, and code comments that illustrate low level design.
• Mentor and guide more junior software developers and consultants, perform code reviews, to ensure overall architecture and code quality is maintained.
• Maintain compliance with applicable policies and procedures for areas such as Quality, Security and Privacy, ensuring that our platform is security and compliant with industry standards.
• Collaborate with other development teams and cross-functionally to gather requirements and translate them to technical solutions.
• Interacts with product managers, project managers, management, other internal and external teams to communicate architecture, status, risks.
• Create and maintains technical product requirements, designs and specifications.
• Provide support to address problems during development and after product release.

• Bachelor degree in related discipline, such as Computer Science, Electrical Engineering or related; master's degree is preferred.
• Strong knowledge of US and global regulatory requirements for medical devices
• Solid technical planning skills to support "Stage Gate" medical device product development.

• A minimum of 5+ years in Software Engineering, with experience working with internal and external teams, development partners and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production
• Successful assembly of 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 QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.
• Healthcare interfaces experience preferred.
• Strong background in object-oriented programming and strong understanding of using design patterns.
• Demonstrated proficiency and fundamental knowledge of Microsoft technologies such as .NET Core, and .NET Framework.
• Experience with service-oriented architecture (SOA) and development of containerized applications.
• Experience with API development using GRPC and HTTP/REST.
• Experience as a software developer in one or more of the following core languages: .NET, C#, JavaScript, TypeScript.
• Front end experience with one or more SPA interfaces, such as Angular, React
• Experience using Visual Studio as a development environment.
• Experience with SDLC, including source control, configuration management, continuous integration pipeline.