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
