Systems Engineer, Health Software

What you'll do

• Develop, manage, and maintain design history files and regulatory deliverables.
• Translate complex technical and regulatory concepts for diverse internal audiences.
• Travel internationally to China to assist with local engineering activities and software testing.
• Conduct impact analyses on design changes and facilitate trade-off discussions among stakeholders.
• Convert product visions into traceable engineering requirements and safe, scalable designs.
• Identify and implement process improvements by building software tools and prototypes.

What we're looking for

• Bachelor's degree in a technical field with 7+ years of relevant industry experience or equivalent combination of education and professional experience.
• Experience in medical device development, specifically Software as a Medical Device (SaMD) or other regulated software products.
• Strong technical fluency in software architecture and development processes to engage in substantive discussions with engineering teams.
• Proven track record of driving alignment and decisions across diverse stakeholder groups.
• Excellent written and verbal communication skills.
• Willingness to travel internationally approximately 10% of the time.
• Knowledge of quality management systems and design controls such as 21CFR820, ISO 13485, IEC 62304, or ISO 14971 (preferred).
• Technical writing skills, project management experience, Mandarin proficiency, and Python/shell scripting (preferred).