Systems V&V Manager

Job title:
Systems V&V Manager
Your role:

Systems V&V Manager provides leadership to the Design Verification &Validation functions which supports the product development business segments throughout the Sleep & Respiratory Group. This Manager must ensure that the Design V&V groups meet commitments and support projects in delivering high quality products on time, within budget, and compliant with applicable regulations.

This position will develop and strive to execute a Design V&V vision that supports a disciplined design and development process. The strategic objectives of Design V&V will be aligned with the strategic objectives of the engineering functions within the business units and the other support functions.

OUTCOMES:

The successful candidate will:

• Define Design V&V group charters, processes, roles, tools, and methods.

• Define the skill sets needed to fulfill the group charters, in line with evolving technologies.

• Recruit, hire, and retain talent with the necessary skills to support projects.

• Conduct performance reviews and on-going coaching and mentoring.

• Negotiate with Project and Functional Managers to determine the support needed.

• Determine individual project assignments, distribute, and balance workload on an on-going basis.

• Help estimate the effort and duration of group support and also help predict testing performance and product quality based on historical data and lessons learned.

• Ensure that project commitments are met and help solve problems when needed.

• Analyze group performance, including estimating and scheduling data, testing/defect data analysis, and capture successes/lessons learned for use on future projects.

BEHAVIORS:

The successful candidate will demonstrate:

• Consider business unit and organizational success criteria as the drivers of Design V&V support and ultimately the success of Design V&V groups.

• Use data to help estimate, plan, and track work effort, product quality, and overall success of teams and the department.

• Provide excellent communication with ability to interact with Design V&V leads, individuals within Design V&V groups, project teams and leaders, and management.

• Instill a sense of engineering discipline, early defect prevention, high quality, and teamwork.

• Establish priorities.

• Resolve conflicts across groups/departments/projects

You're the right fit if: (4 x bullets max)

• At least 10 years in medical device or similar V&V industry; 5+ years in supervising, managing, or leading teams and individuals; 5+ years in medical or other regulated industry.

  
  

  Preferred experience includes:

  
  

  • Experience in Systems Verification of products, technologies, inter-relationships across business segments and disciplines.

  
  

  • Experiences in System Verification strategies and methodologies

  
  

  • Experiences in Verification & Product Lifecycle Management (PLM) Tools, such as DOORS, HP ALM, JAMAsoft, JIRA, etc

  
  

  • Analysis of control systems involving air flow from device to patient: motors, blowers, pressure and flow sensors, complex software algorithms, masks.

  
  

  • Test automation and management tools, such as Test Director and LabView.

  
  

  • Experience working in disciplined, regulated industries; medical device experience preferred, including FDA’s 21 CFR 820/ISO 13485 experience.

  
  

  • Experience with 14971 (risk management) and ISO 62304 (software) standards.

  
  

  • Experience with IEC 60601 series of Medical Equipment Standards

  
  

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.