Verification & Validation Manager

About the role

B. Braun Medical Inc. is seeking a V&V Engineer to lead and oversee the teams, processes, and tools responsible for product verification and software validation testing. This role supports the creation and maintenance of test cases and protocols to ensure product and software quality standards are achieved, and regulatory expectations are met. The role also involves overseeing the execution and reporting of Verification test efforts, including document approval and release.

Responsibilities

• Develop, lead, and manage the V&V engineering group.
• Define and track goal progress for individual team members.
• Support the development and maintenance of Product and Software Requirements Specifications.
• Develop test cases, protocols, and plans; Perform and oversee execution of these test cases, protocols, and plans; Deliver final test reports.
• Hardware and system testing against the product requirements, including testing against optical standards, visual perception and mechanical capability.
• Preparation for and Management of External Testing, including: Safety testing per IEC-60601-1, Wireless, Shipping, EMC Testing, etc.
• Understand accelerated lifecycle testing to prove reliability.
• Software verification testing against the software requirements specifications.
• Introduce V&V best practices in compliance with FDA and EU medical device product development, and measure team performance against best practices.
• Develop test automation framework to achieve (1) early defect detection and (2) reduced manual test effort.
• Manage hardware and software resources required to support testing.
• Work with project managers to ensure that projects are completed on time, and within budget.
• Contribute as needed to help the V&V team to achieve project goals and milestones.
• Act as the technical point-of-contact for customer reports issues and provide support to the Technical Support team as needed.

Qualifications

• Mandatory: Requires a minimum 8-10 years’ experience in medical device development with a bachelor’s degree or 5-7 years’ experience in medical device development with a Master’s Degree in science/engineering from an accredited university, or equivalent work experience in medical device development.
• Minimum of 2 years’ experience supervising technical staff.
• Desirable: Experience developing medical devices, or working in a regulated environment; Understanding of IEC-60601-1, IEC-14971, and IEC-62304 for medical device development; Experience being in the operating room (OR) supporting live surgeries as a design engineer, tech. support, service engineer, or sales representative; Knowing OR sterility protocols, medical equipment; Understanding basic image processing concepts and techniques; Hands-on background in operation and use of standard test equipment; oscilloscopes, digital multimeters, frequency generators, calipers etc.; Ability to troubleshoot and analyze electronics; Background in software test automation; Knowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, X-rays, CT scans, MRI, OCT, etc.; Experience working with Scrum/Agile; Strong computer skills, knowledge of Microsoft Word, Excel and Outlook; Ability to troubleshoot PC-based systems, hardware, and software.

Competencies

• Ability to manage V&V team members.
• Understanding of medical device product regulations, FDA and EU.
• Demonstrated ability to creatively and proactively solve problems.
• Flexible in working under changing and different work settings.
• Demonstrate knowledge of the company product development lifecycle and the process tools.

Benefits

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. For more information, visit us at www.bbraunusa.com.