DO YOU HAVE THE RIGHT STUFF? We are seeking a Systems Verification Director with FDA-regulated medical device experience, an engineering background, and proven leadership skills to lead a research and design center in Pittsburgh, PA. You will set up the strategy and manage the Systems Verification & Validation group for robotics products, be the safety net for the entire organization, ensuring only the best quality products are released to customers. This leader will work with cross-functional teams and their leaders to drive the test strategy and execution for new product development and to implement industrial best practices. Relocation package included.

 

Systems Verification Director Benefits

• Salary range of $170K - $200K
• Bonus Opportunity
• Comprehensive healthcare benefits package
• PTO
• 401k with match
• Relocation assistance

System Verification Director Qualification

• 10+ years' experience in R&D/Technical leadership roles in an FDA-regulated medical device environment with a proven track record of bringing sophisticated medical products to market
• 10+ years' experience leading engineering teams and managing budgets
• 5+ years' experience in System V&V efforts
• Expertise in complex electro-mechanical systems, software, embedded firmware-based systems, computer-assisted surgery, and robotics. Computer vision systems experience is a plus
• Working knowledge of ISO 13485. IEC 62304, IEC 60601, and AAMI TIR-45 standard
• 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

 

System Verification Director Responsibilities

• Lead the Systems Verification & Validation group, oversee strategy development, and manage both in-house and offshore test teams in an FDA regulated medical device environment
• 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 and report test dashboard related to product testing and product quality
• Ensure compliance with quality management system requirements, enhancing test efficiency and effectiveness

At Goodwin Recruiting we are committed to our core values. We take our value, Dedicated to Diversity & Inclusion, very seriously and will never discriminate against a candidate or client based on any protected classes. Our clients seek qualified candidates, and that is what we deliver. A person's age, gender, race, sexual orientation, gender identity, national origin, veteran or disability status, or arrest or conviction record has no bearing on whether he, she, or they are able to do the job. We evaluate the knowledge, skills, and abilities that meet the requirements of the position and aim to open doors and change lives. We value all people, understanding that uniqueness and diversity foster a stronger team that is innovative and brings varying perspectives to the table. We put our money where our mouth is and are proud of our efforts to identify a broad slate of candidates, with many hiring success stories to share.   JOB ID: 136063 #post

Mitch Rachman