Sr Staff SW QA Engineer

The opportunity to improve health on a global scale stands before us.

Provides technical leadership for software quality assurance activities, including risk management activities following ISO 14971, with a focus on Product Model and Clinical Apps . Supports the development and implementation of scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance.

Partners with senior R&D engineering, Quality, Regulatory, Clinical, Cybersecurity, and business leaders to drive continuous improvements to SDLC, and quality excellence throughout the product lifecycle. Influences organizational quality strategy and serves as a recognized subject matter expert in supporting Clinical product portfolio, risk management, and regulatory compliance.

* Develop and drive enterprise-level software quality strategies, policies, procedures, and best practices across the Clinical Applications and Hospital space.

* Serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities.

* Lead the effective application, compliance, and continuous improvement of software development and V&V processes, including:

* Lead complex software quality initiatives spanning multiple products, programs, and functional organizations.

* Lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.

* Lead digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304.

* Provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.

* Review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content.

* Drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes.

* Evaluate emerging regulations, standards, and industry trends and assess impact to existing and future products.

* Collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps, implementing a right-sized QMS for Non-Clinical applications.

* Mentor and provide technical leadership to software quality engineers and cross-functional development teams.

* Influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations.

* Extensive medical device experience demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements.

* Expert knowledge of software development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation.

* Deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities.

* Advanced understanding of software risk management principles, methodologies, and regulatory expectations.

* Demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority.

* Strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.

* Experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors.

* Exceptional written, verbal, and executive-level communication skills.

* Ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion.

* Demonstrated success mentoring engineers and developing organizational quality capabilities.

Typically requires a Bachelor's degree in a technical discipline, and a minimum

of 13+ years related experience or a Master's degree and 8+ years

equivalent industry experience of a PhD and 5+ years of experience.