Role Description
• Drive end-to-end Software Development Life Cycle (SDLC) for healthcare projects (SAMD).
• Translate complex system-level requirements into actionable software use cases and user stories.
• Support team with design inputs that strictly adhere to the Arthrex Quality Management System (QMS) and international regulatory frameworks to minimize compliance risks.
• Take ownership of the Design History Files (DHF) and Design Control Documentation including maintaining technical records and coordinating with regulatory teams to ensure a seamless path to certification and market entry.
• Provide technical support during high-stakes audits conducted by the FDA, Notified Bodies, and other regulatory agencies by maintaining transparent and accurate documentation.
• Actively monitor software project health, identify potential bottlenecks early, and implement corrective actions to keep the development schedule on track.
• Participate in the review of design verification plans and procedures to make sure the software performs reliably under real-world conditions.
• Analyze software product complaints by performing detailed root cause failure analysis.
Skill Requirements
PRIMARY SKILLS (MUST-HAVE SKILLS):
• In-depth experience of developing software products in healthcare domain (SAMD – Software as a Medical Device)
• Formal degree or extensive experience with biomedical engineering
• Knowledge of project management tools and methodologies used to oversee the entire project lifecycle
• Exposure to application of healthcare systems engineering, specifically about how software integrates with hardware and user environments
• In-depth knowledge of software project documentation in medical domain, e.g., design history files, security & compliance documentation etc.
• Experience dealing with regulatory standards such as FDA and IEC 62304
• Ability to translate complex engineering challenges into clear, actionable insights, ensuring that all stakeholders are informed and aligned on project status and technical needs
• Thorough understanding of Agile and Scrum methodologies within the Software Development Life Cycle
SECONDARY SKILLS: (GOOD TO HAVE)
• Knowledge of orthopaedic surgery domain
• Experience with PLM tools like Windchill
• Exposure to CAD (Computer Aided Design) tools like AutoCAD, SOLIDWORKS etc.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
• Bachelor’s / Master’s degree in Biomedical Engineering , Computer Science, Computer Engineering, or similar field
