Job Summary

The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service.

Key Accountabilities

• Provide software expertise, leadership, and direction throughout the software development lifecycle with a focus on appropriate and thorough testing.
• Function as a quality expert for all product development activities by ensuring compliance to applicable standards and regulations.
• Maintain up-to-date knowledge on cybersecurity requirements and provide leadership and guidance regarding implementation and compliance.
• Write, review and approve software release documentation and change orders.
• Provide leadership and guidance in software change control for defect tracking and resolution.
• Function as the quality expert in software risk management processes throughout the entire software lifecycle.
• Provide expertise in non-product software validation for software tools used in product manufacturing, product testing and the quality system.
• Provide software quality engineering expertise to relevant CAPAs and audits.
• Maintain up-to-date knowledge on software development tools and processes.
• Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle
• Advises and directs teams regarding compliance of software to procedures, standards and regulations including those related to cybersecurity and privacy requirements. Implements changes to procedures in alignment with evolving regulations.
• Participates on core teams supporting new product development or design changes
• Defends relevant quality topics in audits and supports corrective actions to improve and maintain compliance of the QMS
• Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
• Provides input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
• Works with Project Management, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
• May supervise the work of others
• Leads cross-functional projects on technical and quality issues
• Identifies compliance gaps and suggest appropriate corrective actions as needed
• Supports internal and external audits
• Leads quality system improvement projects as required
  
  

Networking / Key Relationships

• Manufacturing/Operations
• Manufacturing Engineering
• Regulatory Affairs
• Research & Development
• Service

Minimum Knowledge & Experience required for the position:

• Bachelor's of Science degree plus a minimum of 12 years related experience or Master's Degree plus a minimum of 9 years related experience or waiver based on experience.
• ASQ SQE certification preferred
• Additional experience working in or knowledge of:
  
  • Software Engineering Platforms and Applications (Cloud-Based Preferred)
  • Project design, validation, quality plans and risk management (including human factors and Cybersecurity)
  • Preparing submissions, complaint systems and/or authorities reporting activities
  • AI/ML models (desirable)
• Solid knowledge and experience working with medical device international regulations (FDA QSR, EU Medical Device Regulation, etc.) and related standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366, TIR 57, etc.)
• Language: English

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Deep knowledge of domestic and international quality/regulatory standards related to both Software in and Software as a Medical Device products (21 CFR Part 820, 21 CFR Part 11, ISO 13485, IEC 62304)
• Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions.
• Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering.
• Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
• Membership on external standards organizations of industry groups with influence of our products – desirable.
• Advanced understanding of software Development Life Cycle Models
• Advanced understanding of Software Configuration Management (SCM)
• Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971)
• Advanced understanding of software development and testing processes

Travel requirements:

Approximately 15% of time