Role: Director, Systems Verification

Position Overview

If you are looking for an amazing opportunity where you can combine your engineering skills with your passion to apply Robotics to medicine and healthcare, then this is the position for you. This is kind of the position you will have tremendous pride talking about with your friends and family. You will be part of a very talented team that is highly motivated and passionate about our vision which simply is "Life Unlimited". The position is in Pittsburgh, PA which is rapidly becoming the premier location for everything Robotics. You will take great pride in seeing the impact of everything you are involved in developing, having a tremendous impact on lives of patients and clinicians.

You are responsible to setup strategy for the Systems Verification & Validation group, manage the Systems V&V team as well as manage and leverage the large 3rd party offshore test team. Your team is responsible for from System Integration to System V&V of Robotics products in the company. Systems V&V group serve as the safety net for the entire organization, ensure only the best quality products being released to customers. This leader will work with cross functional teams and their leaders to drive the test strategy and execution for the new product development. The leadership role will elevate the maturity level of test team, by bringing in and implementing industrial best practices.

RESPONSIBILITIES

• Lead the Systems Verification & Validation group, overseeing strategy development and managing both in-house and offshore test teams.
• Recruit, retain and mentor employees and contractors.
• Collaborate with R&D teams in both Waterfall and Agile environments to ensure cohesive V&V efforts.
• Spearhead innovation in system integration, verification, and validation, implementing best practices such as test-driven design, BDD, test automation, and AI-assisted test development.
• Drive system integrations, system verification and validation activities including V&V strategy, planning, test cases generation/review, summary report generation/review, and traceability.
• Define and manage test environments, including equipment inventory, validation, and procurement.
• Coordinate with functional leads to align NPD System V&V planning and execution with project goals.
• Develop and track KPIs, report test dashboard related to product testing and product quality.
• Ensure compliance with quality management system requirements, enhancing test efficiency and effectiveness.

QUALIFICATIONS

• Minimum of 10 years' experience in R&D/Technical leadership roles in the medical technology industry, with a proven track record of bringing sophisticated medical products to market.
• Minimum of 10 years' experience leading engineering teams and managing budgets.
• Minimum of 5 years' experience in System V&V efforts.
• Expertise in complex electro-mechanical systems, software, embedded firmware-based systems, computer-assisted surgery, and robotics.
• Strong written and oral communication skills, with a demonstrated ability to interact with Executive Management.
• Positive attitude, fostering a culture of collaboration and accountability.
• Ability to work effectively with geographically distributed and diverse teams.
• Bachelor's degree in Computer Engineering, Electrical Engineering, or related fields.

PREFERRED QUALIFICATIONS, EDUCATION and/or EXPERIENCE

• Experience with FDA regulated medical devices.
• Experience with AAMI TIR-45 standard
• Experience with Robotics and Computer Vision systems.
• Working knowledge of ISO 13485, IEC 62304, IEC 60601, Agile Development Methodologies.

Location: Pittsburgh, PA

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.