Manager, Systems V&V

　　Requisition Number 2734

　　Location US - Marlborough, MA

　　State/Territory Massachusetts

　　Essential Job Functio

　　· Manage day to day activities of the Product Qualification (V&V) team by setting priorities according to the department and corporation’s overall strategic plans.

　　· Possess a deep understanding of systems engineering methodologies supporting integration and experimentation as well as product/system verification and validation

　　· Lead System Verification and Validation (V&V) activities in a FDA regulated environment that meets internal quality requirements and regulatory standards for Class I/II medical devices (FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 62366)

　　· Liaise with external test houses for execution of testing and certification against established product standards (e.g. IEC 60601, ISO 10993, ASTM D4169)

　　· Utilize system engineering methodologies and analysis approach to the definition and execution of V&V plans, protocols, and reports including risk management mitigation (working closely with System Engineers, Design Quality Assurance (DQA) and/or Product Risk Management)

　　· Fully understand field issues and drive a data informed test strategy utilizing data fueled analysis and field stimulation to reduce field issues/complaints

　　· Demonstrate cross-functional collaboration to ensure system and sub-system requirements are measurable, testable and meet quality system requirements

　　· Participate and lead new product development processes to ensure product/system level requirements (MRD, PRD) have traceable product/system level test cases and/or reports.

　　· Work with counterparts in Hardware Test and Software Test to coordinate design verification and validation activities at the subsystem design level

　　· Responsible for the design and execution of product/system verification and validation test procedures for Candela devices.

　　· Interact closely with members of the QA, Regulatory, NPI and LCE (sustaining) groups to ensure test processes are aligned to various regulatory requirements.

　　· Ensure systems engineering best practices are utilized to elicit, develop, and manage requirements and test criteria

　　· Support pilot of new RTM tool (JAMA) by integrating best practices, assessing capability, and acting as tool administrator

　　· Ensure development and adherence to best practices for component testing, design verification and design validation, including practical utilization of statistical methods for the determination of product/system test sampling plans

　　· Staff Management: communicating job expectations, planning, monitoring, and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement; enforcing compliance to policies, procedures, and standards

　　· Manage Product Qualification (V&V) project dashboards, KPIs, and team charter(s)

　　· Mentor and manage daily activities of V&V team globally while communicating effectively across multiple functions and levels of the organization

　　· Drive a reduction in field failures through an iterative test approach utilizing field data and improve quality from cradle to grave

　　Knowledge/Educational Requirements

　　· BS or MS (preferred) in mechanical, electrical, biomedical or systems engineering

　　· Minimum of 5 years direct experience in the integration and system verification and validation testing of complex systems in a regulated medical environment. Technical leadership experience preferred.

　　· Minimum of 5 years of people line management experience with demonstrated ability to recruit, coach, mentor, and develop team members.

　　· Working knowledge ofFDA, EU,IEC, AAMI, and ANSI standards relating to medical devices (e.g. ISO 13485, IEC 60601, IEC 60825, ISO 14971, ISO 10993, IEC 62366, FDQ QSR, EUMDR, etc.)

　　· Experience creating DHF and technical file deliverables including Verification and Validation plans, protocols, reports, deviations, risk/benefit analyses and updating traceability matrices

　　· Proficiency with RTM tools (JAMA or Helix preferred) and Microsoft Windows Office tools

　　· Excellent interpersonal, organizational as well as verbal and written communication skills

　　· Must possess project management experience including managing multiple projects utilizing standard project management tools and best practices (e.g.MS Project and/or Smartsheet, Gantt project schedules, burn-down metrics, etc.)