Sr Director Software Engineering Validation and Verification
Sr Director Software Engineering Validation and Verification
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$ 196080 - 294120
1 Vacancy
Job Description
The Sr. Director of Software Development Validation and Verification is responsible for leading a global R&D SV&V organization participating and consulting on activities in all phases of the software development and instrumentation lifecycle with a focus on verification and validation testing of medical devices and connectivity solutions. This role leverages software testing proficiency to translate product requirements into test strategies and document work to ensure compliance within a regulated Product Development Process. The Sr. Director will ensure compliance with regulatory standards manage the software development lifecycle and drive innovation in software solutions.
Key Responsibilities:
- Leadership and Management: Oversee and mentor a team of software developers and engineers fostering a collaborative and productive work environment.
- Software Development: Direct the design implementation and maintenance of software applications ensuring they meet quality and regulatory standards.
- Validation and Verification: Ensure all software products undergo rigorous validation and verification processes to comply with industry regulations (e.g. FDA ISO 13485.
- Innovation and Improvement: Identify and implement best practices and new technologies to enhance software development processes and product quality.
- Project Management: Manage software development projects including planning and reporting to senior management.
- Stakeholder Collaboration: Work closely with internal and external stakeholders including regulatory bodies to ensure successful project outcomes.
- Automated Testing Solutions: Develop automated software testing solutions for medical devices.
- Test Strategy: Create and implement overall software test and automation strategy.
- Test Protocols: Develop automated test protocols for verification of software capabilities as specified in the requirements.
- Requirements Testing: Test the requirements architecture and design for medical devices to meet customer needs.
- Collaboration: Collaborate with the software architect and systems engineers to ensure the software architecture meets specifications and is ready for verification and validation based on hazards and customer needs.
- Documentation: Develop test maintain and document software testing components applications scripts and tools.
- Product Development Participation: Participate in all phases of product development including reviewing requirements architecture design risk assessment and testing .
Qualifications:
- Education: Bachelors degree in Computer Science Engineering or a related field; advanced degrees (MS MBA) preferred.
- Experience: 10 years of software development experience with at least 5 years in a managerial role within the medical device industry.
- Technical Skills: Proficiency in programming languages (e.g. C C# .NET) experience with software development tools and familiarity with regulatory standards (e.g. FDA 21 CFR Part 820.
- Soft Skills: Strong leadership communication and project management skills.
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Pay Range
$196080.00 $294120.00Pay Frequency
AnnualAlcon is an Equal Opportunity Employer and participates in EVerify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Required Experience:
Director
Employment Type
Full-Time
