Quality, regulatory, safety, and risk management

• Ensure software development activities meet Spacelabs Healthcare quality system requirements and applicable medical device regulatory expectations.
• Ensure that required documentation, reviews, approvals, traceability, verification evidence, and signoffs are planned, completed, and maintained.
• Participate in risk/hazard analysis and DFMEA activities for products and ensure software risks are understood, prioritized, mitigated, and communicated.
• Partner with quality, regulatory, clinical, systems engineering, and verification and validation teams to improve design controls, software lifecycle practices, and release readiness.

People leadership and global operating model

• Lead, develop, motivate, and hold accountable a high-performing global software engineering organization, including direct and matrixed team members across multiple geographies.
• Assess department needs, recruit talent, set performance expectations, appraise performance, coach team members, and develop career plans and milestones.
• Build leadership depth within the organization, including managers, technical leaders, architects, product-focused engineers, verification leaders, and sustaining engineering owners.
• Maintain clear communication of vision, priorities, organizational expectations, and execution plans vertically and horizontally across the company.

Stakeholder engagement and business partnership

• Collaborate with product owners, product management, program management, project management, systems engineering, clinical, service, manufacturing, quality, and regulatory partners to maximize the value of delivered software.
• Balance business goals, clinical needs, technical implications, quality requirements, regulatory obligations, schedules, and resource constraints when making decisions.
• Support strategic planning, release planning, escalation management, vendor or partner engagement, and executive communication as required.

Qualifications

• Bachelor’s degree in computer science, software engineering, computer engineering, electrical engineering, or a related technical discipline; advanced degree preferred.
• 15+ years of progressive software development or software product development experience, including experience in a regulated industry such as medical device, aerospace, or another safety-critical environment.
• Proficiency with C++/C#.
• 10+ years managing high-performing software development organizations, including experience managing managers, senior technical leaders, and teams of 20+ across multiple geographies.
• Demonstrated record of delivering commercial software releases in a regulated environment for complex real time and networked systems.
• Strong working knowledge of medical device software lifecycle expectations, including quality management systems, design controls, risk management, verification and validation, traceability, and release documentation preferred.
• Experience with standards and regulatory frameworks relevant to medical device software, such as ISO 13485, IEC 62304, 21 CFR 820/QMSR, risk management, cybersecurity, and related software quality practices preferred.
• Deep technical knowledge of modern software architecture, software design, development, debugging, automated testing, unit and regression test frameworks, and iterative/agile development methodologies.
• Demonstrated experience using engineering metrics, CI/CD, automation, code review, defect management, and software planning methods to improve quality, productivity, and predictability.
• Ability to dive into complex technical issues when needed, guide teams systematically to solutions, and make sound tradeoffs.
• Proven ability to manage multiple complex priorities within demanding timeframes, solve problems, influence stakeholders, and deliver results through direct, matrixed, onshore, offshore, and partner teams.
• Collaborative leadership style with strong relationship-building skills, clear verbal and written communication, and the ability to communicate technical and business information to executives and cross-functional partners.
• Proven ability to lead change management, transform software development practices, and improve organizational effectiveness, productivity, quality, and employee engagement.
• Domestic and international travel up to 25%
• Ability to work with ambiguity.
• Ability to work in multiple time zones.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.