Software Engineer

The Software Engineer will be responsible for working within cross-functional teams to understand requirements and develop medical device software to meet regulatory and customer expectations. The position includes the design and development, prototyping, testing, and documentation of medical device software products.

Job Summary: Software Engineer

• Work on multiple projects to develop new medical device software and update existing products through the software life-cycle process.
• Design, code, test, and document software in compliance with medical device regulations and standards.
• Develop software for feasibility prototypes.
• Work closely with cross-functional groups, including Hardware Engineering counterparts to define product requirements.
• Work closely with Hardware Team for firmware/hardware integration.
• Ensure all product software is developed in accordance with the software development process, including requirements definition, architecture, design, implementation, debugging, and software testing.
• Participate in code reviews and perform module testing.
• Manage software and labeling translation projects.
• Assess software failures as part of customer complaint investigations.
• Provide design solutions for existing software, with particular attention to improvement of overall system performance, ease-of-use, and safety.
• Be capable of owning and completing tasks with the time pressures typical of new product development.
• Understand and adhere to the company’s Code of Ethical Conduct and ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the business.
• Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
• Represent software development in product development teams, including design reviews.
• Organize and conduct software technical reviews and software development phase reviews.
• Perform other duties as assigned.

Essential Functions:

• Write correct, readable, maintainable, and testable software.
• Maintain and improve the quality of all products.
• Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
• Support a work environment of continuous improvement that supports Galen’s Quality Policy, Quality System and the appropriate regulations for the area supported.
• Keep manager informed of changes in work schedule and/or workload.
• Regularly recommend and implement methods of improving the customer experience.

Education Requirements:
Minimum BSCS

Experience Requirements:
Minimum 4 years of industry software engineering experience.

Skills/Qualifications/Competencies:

• C++ (11 or newer).
• OOP.
• Developing Linux (primarily) and OS – independent software.
• Library design is strongly preferred.
• Ability to solve complex problems in the agreed timeline.
• Strong problem-solving skills.
• Professional and positive approach, self-motivated, team player, creative with the ability to work on own initiative.
• Experience with agile development.
• Excellent written, verbal, and presentation skills.
• Self-motivated, self-directed, and able to thrive in a fast-paced environment.
• Ability to work cross-functionally with a distributed team across Engineering, Design, Customer Success, Marketing and Business Development.
• Experience in the Medical Device Industry strongly preferred.
• Ability to solve complex problems in the agreed timeline.